| 14 May 2024 |
Medical Device Safety Alert: Medtronic Inc. Ascenda Intrathecal Catheter |
|
| 14 May 2024 |
Medical Device Safety Alert: Abbott Medical System Monitor [Used with the HeartMate Left Ventricular Assist System (LVAS)] |
|
| 13 May 2024 |
Medical Device Safety Alert: Medtronic Inc. Arterial Cannulae, Clearview Blower/Mister, DLP Coronary Ostial Cannulae, I.M.A. Cannulae, Left Heart Vent Catheters, Tourniquet Sets, Vessel Cannulae, Aortic Root Cannulae and Cardioplegia Needles, Cardioplegia Adapters, Disposable Pressure Display Sets, Intracoronary Shunts, Suction Tubes, Venous Cannulae |
|
| 10 May 2024 |
醫療儀器安全警示: 羅氏血糖健康醫護公司 Roche Diabetic Care GmbH血糖儀 Accu-Chek Guide blood glucose meter (Chinese Only) |
|
| 10 May 2024 |
Medical Device Safety Alert: Philips Medical Systems Nederland B.V. Zenition 70 Systems |
|
| 09 May 2024 |
Medical Device Safety Alert: Philips Medical Systems Nederland B.V. Philips Interventional Hemodynamic Application R1.2.X, R1.3.0 and R1.3.1 |
|
| 09 May 2024 |
Medical Device Safety Alert: Smith & Nephew, Inc. OXINIUM FEMORAL HEAD 12/14 32MM +4 |
|
| 09 May 2024 |
醫療儀器安全警示: 愛德華茲生命科學有限責任公司 Edwards Lifesciences LLC 乾式主動脈瓣膜 EDWARDS INSPIRIS RESILIA Aortic Valve (Chinese Only) |
|
| 09 May 2024 |
Medical Device Safety Alert: Alcon Laboratories, Incorporated Alcon Ophthalmic Knife, Alcon Ophthalmic V-Lance Knife, Clearcut S Safety Sab Sideport Knife |
|
| 08 May 2024 |
Medical Device Safety Alert: Arrow International LLC Subsidiary Of Teleflex Incorporated Ultra Intra-Aortic Balloon Pumps (IABP) |
|
| 07 May 2024 |
Medical Device Safety Alert: GE Healthcare Finland Oy CARESCAPE Monitoring System |
|
| 04 May 2024 |
Medical Device Safety Alert: Philips Medical Systems Nederland B.V. MR systems with software version R5.7.1 |
|
| 04 May 2024 |
Medical Device Safety Alert: Philips Medical Systems Nederland B.V. MR systems |
|
| 04 May 2024 |
Medical Device Safety Alert: Johnson & Johnson Surgical Vision, Inc. Reusable LAMINAR High Flow Irrigation Sleeve and Test Chamber 21 Gauge |
|
| 02 May 2024 |
Medical Device Safety Alert: Philips Medical Systems Nederland B.V. Philips IQon, iCT, Ingenuity, and Brilliance CT 64 systems |
|
| 02 May 2024 |
Medical Device Safety Alert: Cadwell Industries, Inc. Cascade IOMAX Cortical Module |
|
| 02 May 2024 |
Medical Device Safety Alert: St. Jude Medical (Abbott Medical) Agilis NxT Steerable Introducer |
|
| 02 May 2024 |
Medical Device Safety Alert: Philips Medical Systems Nederland B.V. Philips Ingenia Evolution systems with software R5.7.1 [Ingenia systems: Ingenia 1.5T and Ingenia 3.0T] |
|
| 29 Apr 2024 |
醫療儀器安全警示: 飛利浦醫療系統荷蘭有限公司 Philips Medical Systems Nederland B.V. X射線計算機體層攝影設備 X-Ray Computed Tomography System – Spectral CT (Chinese Only) |
|
| 27 Apr 2024 |
Medical Device Safety Alert: Baxter Healthcare SA Seprafilm Adhesion Barrier |
|
| 26 Apr 2024 |
醫療儀器安全警示: 庫克公司Cook Incorporated血管内抓捕器 (Chinese Only) |
|
| 26 Apr 2024 |
Medical Device Safety Alert: Philips Medical Systems Patient Information Center iX |
|
| 25 Apr 2024 |
Medical Device Safety Alert: Philips Healthcare Incisive CT/CT 3500/CT 5300 System |
|
| 23 Apr 2024 |
Medical Device Safety Alert: Medtronic Inc. Cobalt XT HF Cardiac Resynchronization Therapy Defibrillator and Evera XT DR Defibrillator |
|
| 22 Apr 2024 |
Medical Device Safety Alert: Ion Beam Applications SA IBA Proton Therapy System PROTEUS 235 |
|
| 18 Apr 2024 |
Medical Device Safety Alert: Philips Medical Systems Nederland B.V. Philips Spectral CT7500 |
|
| 15 Apr 2024 |
Medical Device Safety Alert: Applied Medical Resources Corporation Voyant EA020 Electrosurgical Generator |
|
| 15 Apr 2024 |
Medical Device Safety Alert: LeMaitre Vascular, Inc. Syntel Silicone Thrombectomy Catheter |
|
| 12 Apr 2024 |
Medical Device Safety Alert: Medtronic Navigation Inc StealthStation S8 Application |
|
| 11 Apr 2024 |
Medical Device Safety Alert: Taewoong Medical Co.,Ltd. Niti-S Bronchial Uncovered Stent [Both Flare Type] |
|
| 10 Apr 2024 |
Medical Device Safety Alert: DiaMed Holding GmbH DiaClon ABO/D+ Reverse-Group |
|
| 10 Apr 2024 |
Medical Device Safety Alert: Philips Ultrasound LLC Ultrasound System 5500 and 5500CV |
|
| 10 Apr 2024 |
Medical Device Safety Alert: Cook Ireland Limited EchoTip Ultra High Definition Ultrasound Access Needle & EchoTip Ultra Endoscopic Ultrasound Needle |
|
| 09 Apr 2024 |
Medical Device Safety Alert: RaySearch Laboratories AB (publ) RayStation RayPlan 7 through 2024A including some service packs |
|
| 08 Apr 2024 |
Medical Device Safety Alert: Abbott Medical Aveir VR Leadless Pacemakers |
|
| 06 Apr 2024 |
Medical Device Safety Alert: Respironics Inc OmniLab Advanced + (OLA+) devices |
|
| 05 Apr 2024 |
Medical Device Safety Alert: Siemens Healthcare GmbH Artis system |
|
| 05 Apr 2024 |
Medical Device Safety Alert: Synthes GmbH Cortex Screw Stardrive |
|
| 05 Apr 2024 |
Medical Device Safety Alert: Philips Medical Systems Nederland B.V. IntelliSpace Cardiovascular |
|
| 03 Apr 2024 |
醫療儀器安全警示: 高級滅菌産品公司 Advanced Sterilization Products, Inc. 過氧化氫低溫等離子滅菌器Sterilizer, 過氧化氫低溫等離子滅菌系統Sterilizer, 過氧化氫低溫等離子滅菌器, 過氧化氫低溫等離子滅菌系統 (Chinese Only) |
|
| 03 Apr 2024 |
醫療儀器安全警示: 西恩尤斯股份有限公司 Xenios AG 體外心肺支持輔助設備 Xenios Console (Chinese Only) |
|
| 27 Mar 2024 |
Medical Device Safety Alert: Gambro Lundia AB AK 98, 115V BIO/ AK 98, 115V SELF-CARE and AK98 V2 115V BIO VERSION / AK 98 V2 115V BIO SELF CARE/ AK 98 V3 |
|
| 27 Mar 2024 |
Medical Device Safety Alert: Gyrus ACMI, Inc. POWERSEAL Sealer and Divider |
|
| 26 Mar 2024 |
Medical Device Safety Alert: Zimmer Periarticular Locking Plate System and Distal Lateral Fibula Locking Plate Products |
|
| 25 Mar 2024 |
Medical Device Safety Alert: Fresenius Medical Care AG & Co. KGaA Fresenius Medical Care Haemodialysis Machines |
|
| 25 Mar 2024 |
Medical Device Safety Alert: Philips Medical Systems Nederland B.V. Magnetic Resonance (MR) systems |
|
| 22 Mar 2024 |
Medical Device Safety Alert: Thoratec HeartMate 3 LVAS Kits |
|
| 15 Mar 2024 |
Medical Device Safety Alert: Biosense Webster, Inc. CARTO VIZIGO Bi-Directional Guiding Sheath |
|
| 15 Mar 2024 |
醫療儀器安全警示: 邁柯唯重症監護有限公司 Maquet Critical Care AB 呼吸機 (Chinese Only) |
|
| 12 Mar 2024 |
Medical Device Safety Alert: DiaMed GmbH Reagents for antibody screening tests |
|
| 12 Mar 2024 |
Medical Device Safety Alert: Synovis Life Technologies, Inc. (Baxter International Inc.) PERI-GUARD Repair Patch and SUPPLE PERI-GUARD Repair Patch |
|
| 11 Mar 2024 |
Medical Device Safety Alert: Philips Medical Systems Philips CareEvent & Patient Information Center iX (PIC iX) |
|
| 08 Mar 2024 |
Medical Device Safety Alert: Olympus Medical Systems Corp. Single Use Electrosurgical Knife |
|
| 07 Mar 2024 |
Medical Device Safety Alert: GE Medical Systems Information Technologies, Inc. MAC VU360 V1.02 SP05 12 Lead ECG Post Acquisition Preview Screen |
|
| 05 Mar 2024 |
醫療儀器安全警示: 美國西門子醫療系統股份有限公司 Siemens Medical Solutions USA, Inc. 超聲診斷系統 (Chinese Only) |
|
| 04 Mar 2024 |
Medical Device Safety Alert: Gyrus ACMI, Inc. (Olympus) Soltive Premium SuperPulsed Laser System |
|
| 04 Mar 2024 |
Medical Device Safety Alert: Olympus Medical Systems Corp. Colonoscope |
|
| 01 Mar 2024 |
Medical Device Safety Alert: Carl Zeiss Meditec AG VisuMax, VISUMAX 600 & VISUMAX 800 |
|
| 01 Mar 2024 |
Medical Device Safety Alert: Cook Incorporated Chiba Biopsy Needle |
|
| 01 Mar 2024 |
醫療儀器安全警示: 辛迪思有限公司 Synthes GmbH 髓內釘系統 Intramedullary Nailing System、矯形外科（骨科）手術器械-擴髓，灌注，吸引系統 RIA-Reamer Irrigator Aspirator、金屬髓內釘系統Metallic Intramedullary Nailing System、椎間融合器 OPAL (Chinese Only) |
|
| 28 Feb 2024 |
Medical Device Safety Alert: RaySearch Laboratories AB (publ) RayStation/RayPlan |
|
| 27 Feb 2024 |
Medical Device Safety Alert: Thoratec Corporation HEARTMATE 3 LVAS KITS & HEARTMATE 3 OUTFLOW GRAFTS and HEARTMATE II LVAS KITS & HEARTMATE II OUTFLOW GRAFTS |
|
| 26 Feb 2024 |
Medical Device Safety Alert: Fresenius Medical Care AG & Co. KGaA Stay Safe Catheter Extension Luer-Lock 25cm, 32cm & 40cm |
|
| 26 Feb 2024 |
Medical Device Safety Alert: Abiomed, Inc. Automated Impella Controller (AIC) |
|
| 22 Feb 2024 |
Medical Device Safety Alert: Boston Scientific Corporation CRBS POLARSHEATH STEERABLE SHEATH |
|
| 21 Feb 2024 |
Medical Device Safety Alert: Multiple Paclitaxel-Coated Balloons and Paclitaxel-Eluting Stents |
|
| 19 Feb 2024 |
Medical Device Safety Alert: Mobius Imaging, LLC. Airo Mobile CT System |
|
| 19 Feb 2024 |
Medical Device Safety Alert: Medtronic Inc. Abre Venous Self-expanding Stent System |
|
| 19 Feb 2024 |
Medical Device Safety Alert: Boston Scientific Corporation iSLEEVE 14F Expandable Introducer Set |
|
| 16 Feb 2024 |
Medical Device Safety Alert: Phadia AB Phadia 200 and Phadia 200 Software 1.6.12 |
|
| 15 Feb 2024 |
Medical Device Safety Alert: Abiomed Europe GmbH Impella Catheters |
|
| 15 Feb 2024 |
Medical Device Safety Alert: Abiomed Europe GmbH Impella Catheters |
|
| 15 Feb 2024 |
Medical Device Safety Alert: Medtronic Xomed, Inc. NIM Standard Reinforced EMG Endotracheal Tube and NIM CONTAC Reinforced EMG Endotracheal Tube |
|
| 15 Feb 2024 |
Medical Device Safety Alert: B. Braun Melsungen AG Original Perfusor Line |
|
| 15 Feb 2024 |
Medical Device Safety Alert: Philips Medical Systems Nederland B.V. Azurion Systems |
|
| 15 Feb 2024 |
Medical Device Safety Alert: Philips Medical Systems DMC GmbH (Philips North America) ProxiDiagnost N90 and ProxiDiagnost upgrade |
|
| 15 Feb 2024 |
Medical Device Safety Alert: FUJIFILM Corporation Digital X-ray system FDR nano |
|
| 15 Feb 2024 |
Medical Device Safety Alert: Synthes GmbH VA-LCP Clavicle Plate 2.7, shaft, CS1, right |
|
| 14 Feb 2024 |
Medical Device Safety Alert: GE MEDICAL SYSTEMS SCS Senographe Pristina |
|
| 09 Feb 2024 |
Medical Device Safety Alert: BioFire Diagnostics, LLC BIOFIRE Blood Culture Identification 2 Panel |
|
| 08 Feb 2024 |
Medical Device Safety Alert: BioFire Diagnostics, LLC BIOFIRE FILMARRAY Gastrointestinal (GI) Panel |
|
| 07 Feb 2024 |
Medical Device Safety Alert: BioFire Diagnostics, LLC BIOFIRE FILMARRAY Pneumonia Panel and BIOFIRE FILMARRAY Pneumonia Panel plus |
|
| 06 Feb 2024 |
醫療儀器安全警示: 麥克羅醫偉司安神經血管醫療股份有限公司 Micro Therapeutics, Inc. dba ev3 Neurovascular微導管 (Chinese Only) |
|
| 06 Feb 2024 |
醫療儀器安全警示: 威爾遜-庫克醫學公司 Wilson-Cook Medical Incorporated 息肉勒除器 Polypectomy Snare (Chinese Only) |
|
| 05 Feb 2024 |
Medical Device Safety Alert: Philips Medical Systems Nederland Ingenia 1.5T, Ingenia Elition X and Ingenia Ambition X |
|
| 01 Feb 2024 |
Medical Device Safety Alert: Stryker Instruments, a Division of Stryker Corporation Pressure Tourniquet Cuffs |
|
| 31 Jan 2024 |
Medical Device Safety Alert: Gyrus ACMI, Inc. (Olympus) Olympus Soltive SuperPulsed Laser System |
|
| 31 Jan 2024 |
Medical Device Safety Alert: Philips Ultrasound, Inc. (Philips Electronics Australia Ltd) Philips EPIQ Series Ultrasound Systems |
|
| 29 Jan 2024 |
Medical Device Safety Alert: Abbott Ireland Diagnostics Division Alinity i Anti-HBs Reagent Kit |
|
| 25 Jan 2024 |
Medical Device Safety Alert: Medtronic Inc. Cobalt XT DR MRI SureScan Implantable Cardioverter Defibrillator |
|
| 24 Jan 2024 |
Medical Device Safety Alert: Medtronic, Inc Duet External Drainage and Monitoring System (EDMS) |
|
| 22 Jan 2024 |
Medical Device Safety Alert: Philips Medical Systems Nederland B.V. Philips Allura XPER, Allura Centron and Azurion Systems |
|
| 19 Jan 2024 |
Medical Device Safety Alert: Maquet Critical Care AB Servo-n ventilator |
|
| 17 Jan 2024 |
醫療儀器安全警示: Ansell Healthcare Europe NV / Ansell N.P.Sdn. Bhd. 安思爾 N.P. 有限公司 一次性使用滅菌橡膠外科手套 (Chinese Only) |
|
| 17 Jan 2024 |
醫療儀器安全警示: GE ULTRASOUND KOREA, Ltd. 超聲診斷儀的超聲探頭 (Chinese Only) |
|
| 17 Jan 2024 |
醫療儀器安全警示: 貝朗梅爾松根股份有限公司 B. Braun Melsungen AG中心靜脈導管 和 一次性使用中心靜脈導管包 (Certofix 和ProSet Certofix) (Chinese Only) |
|
| 15 Jan 2024 |
Medical Device Safety Alert: Philips Medical Systems Nederland B.V. Ingenia Ambition X and Ingenia Ambition S |
|
| 15 Jan 2024 |
Medical Device Safety Alert: William A. Cook Australia Pty. Ltd. (Cook Medical LLC) MINC+ Benchtop Incubator |
|
| 12 Jan 2024 |
Medical Device Safety Alert: BioFire Diagnostics, LLC BIOFIRE FILMARRAY Gastrointestinal (GI) Panel and The BIOFIRE Respiratory Panel 2.1 (RP2.1) |
|
| 12 Jan 2024 |
醫療儀器安全警示: 愛德華茲生命科學有限責任公司Edwards Lifesciences LLC 心臟瓣膜成形環Annuloplasty Ring (Chinese Only) |
|
| 12 Jan 2024 |
醫療儀器安全警示: 飛利浦醫療系統荷蘭有限公司Philips Medical Systems Nederland B.V. 磁共振成像系統、醫用磁共振成像系統 (Chinese Only) |
|
| 11 Jan 2024 |
Medical Device Safety Alert: Datex-Ohmeda, Inc. (GE HealthCare) EVair and EVair03 Compressors with The CARESCAPE R860 ventilator or Engström Carestation/Pro ventilators |
|
| 09 Jan 2024 |
Medical Device Safety Alert: Abbott Ireland Diagnostics Division Alinity I HBsAg Reagent Kit |
|
| 08 Jan 2024 |
醫療儀器安全警示: 荷蘭飛利浦醫療系統公司 Philips Medical Systems Nederland B.V. 醫用磁共振成像系統、磁共振成像系統Achieva 1.5T、Intera 1.5T (Chinese Only) |
|
| 08 Jan 2024 |
Medical Device Safety Alert: Abiomed Inc. Impella Connect |
|
| 04 Jan 2024 |
Medical Device Safety Alert: ev3, Inc. (Medtronic Inc.) Protege GPS Self-Expanding Peripheral Stent System |
|
| 02 Jan 2024 |
醫療儀器安全警示: 飛利浦醫療系統荷蘭有限公司 Philips Medical Systems Nederland B.V. 醫用磁共振成像系統Magnetic Resonance Equipment Ingenia 3.0T (Chinese Only) |
|
| 02 Jan 2024 |
醫療儀器安全警示: 飛利浦醫療系統荷蘭有限公司 Philips Medical Systems Nederland B.V. X射線計算機體層攝影設備 X-Ray Computed Tomography System (Chinese Only) |
|
| 28 Dec 2023 |
Medical Device Safety Alert: Siemens Healthcare GmbH ARTIS pheno, ARTIS icono biplane and ARTIS icono floor with VE OR Table |
|
| 28 Dec 2023 |
Medical Device Safety Alert: Philips Medical Systems Nederland B.V. Spectral CT 7500 (728333), Spectral CT 7500 China (728340), and Spectral CT on Rails (728334) |
|
| 27 Dec 2023 |
醫療儀器安全警示: 生物梅里埃美國股份有限公司 bioMerieus, Inc 革蘭氏陰性細菌鑑定卡 (Chinese Only) |
|
| 27 Dec 2023 |
醫療儀器安全警示: 愛惜康內鏡外科器械有限責任公司 Ethicon Endo-Surgery, LLC 電動腔鏡直線型切割吻合器和釘倉ECHELON FLEX 45mm Powered Plus Articulating Endoscopic Linear Cutters and ECHELON ENDOPATH Endoscopic Linear Cutter Reloads, 45mm (+ Gripping Surface Technology) (Chinese Only) |
|
| 22 Dec 2023 |
Medical Device Safety Alert: Howmedica Osteonics Corporation Scorpio and Duracon Total Knee Systems |
|
| 22 Dec 2023 |
Medical Device Safety Alert: MEDEX SECUFILL patient lines X50 |
|
| 21 Dec 2023 |
Medical Device Safety Alert: Medivators Inc. Advantage Plus Endoscope Reprocessing System and Advantage Plus Pass Thru Automatic Endoscope Reprocessing System |
|
| 21 Dec 2023 |
Medical Device Safety Alert: Covidien llc Sofsilk Braided Silk Suture and Surgilon Coated Braided Nylon Nonabsorbable Suture |
|
| 21 Dec 2023 |
醫療儀器安全警示: 柯惠有限責任公司Covidien llc 可吸收釘修補固定器 (Chinese Only) |
|
| 21 Dec 2023 |
醫療儀器安全警示: 奧林巴斯醫療株式會社 電子支氣管內窺鏡 [型號: BF-1TQ290、BF-MP290F、BF-H290] (Chinese Only) |
|
| 19 Dec 2023 |
Medical Device Safety Alert: Abbott Medical TactiFlex Ablation Catheter, Sensor Enabled (A-TFSE-FJ) |
|
| 19 Dec 2023 |
Medical Device Safety Alert: Philips Medical Systems Nederland B.V. Philips Azurion System R1.0, R1.1, R1.2, R2.0, R2.1, and R2.2 |
|
| 19 Dec 2023 |
Medical Device Safety Alert: Philips Medical Systems Nederland B.V. Philips Azurion 7 M20 FlexArm system with Maquet Magnus Table |
|
| 18 Dec 2023 |
Medical Device Safety Alert: Q-Med AB Sculptra Poly L Lactic Acid Vials 150mg Powder for Injection |
|
| 18 Dec 2023 |
Medical Device Safety Alert: Abbott Ireland Diagnostics Division Alinity i HBsAg Reagent Kit |
|
| 15 Dec 2023 |
Medical Device Safety Alert: Philips Medical Systems Nederland B.V. Azurion Systems with software release R2.2.0, R2.2.1, R2.2.3, R2.2.5 and R2.2.6 |
|
| 12 Dec 2023 |
Medical Device Safety Alert: Medtronic Inc. SynchroMed |
|
| 07 Dec 2023 |
Medical Device Safety Alert: Medtronic Navigation, Inc. Sterile Percutaneous Reference Pin |
|
| 07 Dec 2023 |
Medical Device Safety Alert: Abiomed Europe GmbH Impella Introducer Kits |
|
| 06 Dec 2023 |
醫療儀器安全警示: 蔚藍紐帶科技有限公司Blue Belt Technologies, Inc. 膝關節置換手術導航系統 Surgical Navigation System (Chinese Only) |
|
| 06 Dec 2023 |
醫療儀器安全警示: 奧林巴斯醫療株式會社 纖維鼻咽喉內窺鏡、電子膀胱腎盂內窺鏡、電子膀胱腎盂鏡、纖維膀胱腎盂鏡 CYF-VH, CYF TYPE V2, CYF-5, ENF TYPE XP (Chinese Only) |
|
| 06 Dec 2023 |
醫療儀器安全警示: 辛迪思有限公司Synthes GmbH顱頜面外科內固定系統 Cranio-Maxillofacial System (Chinese Only) |
|
| 06 Dec 2023 |
醫療儀器安全警示: 美國施樂輝有限公司Smith & Nephew, Inc. 髖臼系統 R3 Acetabular System (Chinese Only) |
|
| 06 Dec 2023 |
醫療儀器安全警示: 史派克公司 Spectranetics Corporation 一次性使用鐳射光纖導管CLiRpath Turbo & Turbo elite Excimer Laser Ablation Catheters (Chinese Only) |
|
| 05 Dec 2023 |
Medical Device Safety Alert: St. Jude Medical TactiSys Quartz Equipment |
|
| 04 Dec 2023 |
Medical Device Safety Alert: Boston Scientific Corporation Zoom Programming System |
|
| 04 Dec 2023 |
Medical Device Safety Alert: Apatech Limited Ostene Bone Hemostasis Material |
|
| 04 Dec 2023 |
Medical Device Safety Alert: Baxter Healthcare SA Hemostatic Products |
|
| 04 Dec 2023 |
Medical Device Safety Alert: Synovis Life Technologies, Inc. (A subsidiary of Baxter International Inc.) Synovis Intravascular Probes, Shunts and Patches |
|
| 04 Dec 2023 |
Medical Device Safety Alert: Philips Medical Systems PIC iX Version 4.X and CareEvent Version C.03.X |
|
| 01 Dec 2023 |
Medical Device Safety Alert: Siemens Shanghai Medical Equipment Ltd Luminos Fusion |
|
| 29 Nov 2023 |
Medical Device Safety Alert: Advanced Sterilization Products, Inc. STERRAD 100NX Sterilizers and STERRAD NX Sterilizers |
|
| 27 Nov 2023 |
醫療儀器安全警示: 奧林巴斯醫療株式會社 電子腹腔內窺鏡 [涉及產品的型號、規格及批次: LTF-S190-5; LTF-S190-10] (Chinese Only) |
|
| 23 Nov 2023 |
Medical Device Safety Alert: B. Braun Melsungen AG Sequent Neo 2.0 x 10mm and 2.5 x 20mm |
|
| 23 Nov 2023 |
Medical Device Safety Alert: ACON Biotech (Hangzhou) Co., Ltd. ACON FLOWFLEX SARS-CoV-2 |
|
| 21 Nov 2023 |
Medical Device Safety Alert: Medtronic Inc. SynchroMed II pump [Model 8637] |
|
| 21 Nov 2023 |
Medical Device Safety Alert: B. Braun Melsungen AG SeQuent Please Neo (Paclitaxel releasing Rapid Exchange PTCA Balloon Catheter) |
|
| 20 Nov 2023 |
Medical Device Safety Alert: Medtronic Valleylab FT10 FT Series Energy Platform |
|
| 17 Nov 2023 |
Medical Device Safety Alert: Philips Medical Systems Nederland B.V. Ingenuity CT and Brilliance CT 64 with software version 4.1.7 |
|
| 16 Nov 2023 |
Medical Device Safety Alert: ResMed Limited ResMed Masks with Magnets |
|
| 16 Nov 2023 |
Medical Device Safety Alert: Ion Beam Applications S.A. IBA Proton Therapy System – PROTEUS 235 |
|
| 16 Nov 2023 |
Medical Device Safety Alert: Bard Peripheral Vascular, Inc Mission Disposable Core Biopsy Instrument and Kit |
|
| 14 Nov 2023 |
醫療儀器安全警示: 北京通用電氣華倫醫療設備有限公司 數字化攝影X射線機 Definium Tempo, Definium Tempo Pro (Chinese Only) |
|
| 13 Nov 2023 |
Medical Device Safety Alert: Siemens Healthcare GmbH ARTIS icono biplane, ARTIS icono floor and Artis pheno with Large Display |
|
| 13 Nov 2023 |
Medical Device Safety Alert: Stryker Corporation Stryker Portal Entry Kit [REF: CAT00241] |
|
| 13 Nov 2023 |
Medical Device Safety Alert: Epocal Inc. epoc NXS Host |
|
| 13 Nov 2023 |
醫療儀器安全警示: 西門子醫療系統有限公司 Siemens Healthcare GmbH 數字化X射線攝影透視系統, 數字化泌尿X射線系統, 數字化X射線攝影透視系統 Luminos Agile Max; Uroskop Omnia Max; Luminos dRF Max (Chinese Only) |
|
| 10 Nov 2023 |
Medical Device Safety Alert: Philips Medical Systems DMC GmbH CombiDiagnost R90, DigitalDiagnost 4, DigitalDiagnost C90, EasyDiagnost Eleva DRF and ProxiDiagnost N90 |
|
| 09 Nov 2023 |
Medical Device Safety Alert: Merit Medical Systems, Inc. Merit Maestro Microcatheter |
|
| 09 Nov 2023 |
Medical Device Safety Alert: Philips Allura and Azurion Systems |
|
| 08 Nov 2023 |
Medical Device Safety Alert: B. Braun Melsungen AG Coroflex ISAR Neo 2.5x19 mm & Coroflex ISAR Neo 2.75x24 mm |
|
| 08 Nov 2023 |
Medical Device Safety Alert: Medtronic Xomed Inc NIM Trivantage EMG Endotracheal Tube |
|
| 07 Nov 2023 |
Medical Device Safety Alert: Instrumentation Laboratory Co. Gem Premier 3500, 4000, 5000 |
|
| 06 Nov 2023 |
Medical Device Safety Alert: Olympus Winter & Ibe GmbH ENDOEYE HD II |
|
| 02 Nov 2023 |
Medical Device Safety Alert: Philips Achieva 1.5T, Achieva 1.5T Conversion, Ingenia 1.5T CX, Intera 1.5T, Intera 1.5T Power/Pulsar, SmartPath to dStream for 1.5T |
|
| 02 Nov 2023 |
Medical Device Safety Alert: BioMérieux BIOFIRE Blood Culture Identification 2 (BCID2) Panel |
|
| 02 Nov 2023 |
醫療儀器安全警示: 奧林巴斯醫療株式會社電子上消化道內窺鏡 (Chinese Only) |
|
| 01 Nov 2023 |
Medical Device Safety Alert: Balt Extrusion SAS HYBRID and SONIC |
|
| 01 Nov 2023 |
Medical Device Safety Alert: Philips Big Bore RT, Brilliance CT Big Bore, Brilliance CT Big Bore Oncology |
|
| 31 Oct 2023 |
Medical Device Safety Alert: Medtronic HeartWare Ventricular Assist Device (HVAD) |
|
| 26 Oct 2023 |
Medical Device Safety Alert: Siemens Healthcare GmbH ARTIS icono ceiling |
|
| 24 Oct 2023 |
醫療儀器安全警示: 美敦力公司Medtronic Inc (美敦力) 植入式心臟起搏器Implantable Pacemaker 、經導管植入式無導線起搏系統Transcatheter Leadless Pacing System 、植入式心電事件監測器Insertable Cardiac Monitor (ICM) (Chinese Only) |
|
| 24 Oct 2023 |
醫療儀器安全警示: Philips Medical Systems Nederland BV飛利浦醫療系統荷蘭有限公司 醫用血管造影X射線系統，移動式C形臂X射線機，移動式C形臂X射線系統 (Chinese Only) |
|
| 24 Oct 2023 |
Medical Device Safety Alert: Bard PowerPICC 5Fr SL IR 135cm, PowerPICC 6Fr TL IR 135cm, PowerPICC SV 4F DL Sherlock, PowerPICC SOLO 5Fr DL IR 70cm and Groshong PICC 4F SL Bas |
|
| 24 Oct 2023 |
醫療儀器安全警示: 美國施樂輝有限公司Smith & Nephew, Inc 全膝關節系統 Journey II knee system (Chinese Only) |
|
| 20 Oct 2023 |
Medical Device Safety Alert: Philips Ultrasound, Inc. EPIQ Diagnostic Ultrasound System |
|
| 18 Oct 2023 |
Medical Device Safety Alert: Olympus Medical Systems Corp. Bronchoscopes |
|
| 18 Oct 2023 |
醫療儀器安全警示: 西門子醫療系統有限公司Siemens Healthcare GmbH 醫用血管造影X射線機 ARTIS pheno, ARTIS icono biplane (Chinese Only) |
|
| 18 Oct 2023 |
醫療儀器安全警示: 西門子醫療系統有限公司 Siemens Healthcare GmbH X射線血管造影圖像處理軟Syngo Application Software (Chinese Only) |
|
| 18 Oct 2023 |
Medical Device Safety Alert: Philips Medical Systems Nederland B.V. Philips Ingenia Elition S and MR 7700 Systems with SW version R5.9 |
|
| 17 Oct 2023 |
Medical Device Safety Alert: Baxter Healthcare SA EVO IQ Syringe Pump |
|
| 17 Oct 2023 |
Medical Device Safety Alert: Invatec S.p.A. Mo.Ma.Ultra |
|
| 17 Oct 2023 |
Medical Device Safety Alert: Olympus Medical Systems Corp Olympus Endoscopes (Multiple Models) |
|
| 16 Oct 2023 |
Medical Device Safety Alert: Siemens Healthcare GmbH Cios Spin, Cios Alpha, Cios Flow with VA30 |
|
| 13 Oct 2023 |
Medical Device Safety Alert: Teoxane S.A. Teosyal Puresense Redensity I |
|
| 13 Oct 2023 |
Medical Device Safety Alert: Alcon Research, LLC Constellation Vision System |
|
| 12 Oct 2023 |
Medical Device Safety Alert: Atrium Medical Corporation Advanta V12 |
|
| 10 Oct 2023 |
Medical Device Safety Alert: Abbott a subset of Assurity and Endurity Pacemakers |
|
| 10 Oct 2023 |
Medical Device Safety Alert: Edwards Lifesciences LLC TruWave Disposable Pressure Transducer, FloTrac Sensors and Acumen IQ Sensors |
|
| 09 Oct 2023 |
Medical Device Safety Alert: Olympus Medical Systems Corporation EVIS X1 Video System Center Olympus |
|
| 04 Oct 2023 |
Medical Device Safety Alert: Fresenius Medical Care AG & Co. KGaA stay safe Disinfection Cap |
|
| 03 Oct 2023 |
Medical Device Safety Alert: Respironics California LLC V60/V60 Plus Ventilator |
|
| 03 Oct 2023 |
Medical Device Safety Alert: Olympus Medical Systems Corp. Thunderbeat Front-Actuated Grip Type S |
|
| 03 Oct 2023 |
Medical Device Safety Alert: Olympus Medical Systems Corp. EVIS EXERA III GASTROINTESTINAL VIDEOSCOPE |
|
| 03 Oct 2023 |
Medical Device Safety Alert: Philips Medizin Systeme Boblingen GmbH EarlyVue VS30 Vitals Monitor & EarlyVue VS30 Vital Signs Monitor |
|
| 03 Oct 2023 |
Medical Device Safety Alert: Stryker Endoscopy, a Division of Stryker Corporation Cinchlock SS Knotless Anchor Inserter [Part Number CAT02462; Lot # 19175AE2] |
|
| 03 Oct 2023 |
Medical Device Safety Alert: GE Medical Systems Ultrasound & Primary Care Diagnostics LLC Venue Go Standard Carts (Ref: H45181VC and H45103VCW), used with Venue Go R2, R3, R4 systems |
|
| 29 Sep 2023 |
Medical Device Safety Alert: Medtronic Navigation Inc StealthStation S8 and StealthStation FlexENT systems [Model Number: 9735762; Version 2.0 and 2.0.1] |
|
| 29 Sep 2023 |
Medical Device Safety Alert: Boston Scientific EXALT Model D Single-Use Duodenoscope |
|
| 27 Sep 2023 |
Medical Device Safety Alert: Abiomed Inc. Impella 5.5 with SmartAssist heart pumps |
|
| 25 Sep 2023 |
Medical Device Safety Alert: BALT Extrusion SAS Hybrid Guidewire |
|
| 19 Sep 2023 |
醫療儀器安全警示: InBody Co., Ltd 電子血壓計 (Chinese Only) |
|
| 19 Sep 2023 |
Medical Device Safety Alert: 卡爾蔡司醫療技術（德國）股份有限公司Carl Zeiss Meditec AG 人工晶狀體 (Chinese Only) |
|
| 19 Sep 2023 |
Medical Device Safety Alert: Intuitive Surgical Inc da Vinci Xi/X Instrument Arm Drapes |
|
| 19 Sep 2023 |
Medical Device Safety Alert: Philips Medical Systems DMC GmbH CombiDiagnost R90 and ProxiDiagnost N90 |
|
| 18 Sep 2023 |
醫療儀器安全警示: 富士膠片株式會社數字化乳腺X射線診斷系統 (Chinese Only) |
|
| 18 Sep 2023 |
醫療儀器安全警示: 美敦力公司Medtronic Inc. 植入式腦深部刺激延伸導線、植入式脊髓神經刺激電極、植入式脊髓神經刺激延伸導線套件、植入式脊髓神經刺激電極套件 (Chinese Only) |
|
| 18 Sep 2023 |
Medical Device Safety Alert: SenTec AG Membrane Changer Single-Use, Membrane Changer Reloadable, Membrane Changer Insert |
|
| 14 Sep 2023 |
Medical Device Safety Alert: Baxter Healthcare Corporation Welch Allyn Connex Spot Monitor |
|
| 14 Sep 2023 |
Medical Device Safety Alert: Zimmer Biomet Pty Ltd Zimmer Dermatome Blades |
|
| 13 Sep 2023 |
Medical Device Safety Alert: Ethicon, Inc Coated VICRYL Plus Antibacterial (polyglactin 910) Suture [Product Code: VCP1226H, Lot: SJBCGZS0] |
|
| 12 Sep 2023 |
Medical Device Safety Alert: Siemens Healthcare Gmbh Magnetom MRI System |
|
| 12 Sep 2023 |
Medical Device Safety Alert: Stryker Instruments, a Division of Stryker Corporation Stryker Bipolar Forceps and Generator |
|
| 11 Sep 2023 |
Medical Device Safety Alert: Philips Medical Systems Nederland B.V. Ingenia Ambition X and Ingenia Ambition S MR Systems |
|
| 11 Sep 2023 |
Medical Device Safety Alert: GE Healthcare Finland Oy F2-01 Frame and CARESCAPE ONE and CARESCAPE Canvas 1000 patient monitors |
|
| 11 Sep 2023 |
Medical Device Safety Alert: B. Braun Melsungen AG PERFUSOR LINE |
|
| 07 Sep 2023 |
醫療儀器安全警示: 西門子醫療系統有限公司Siemens Healthcare GmbH X射線診斷系統 、數字化X射線攝影透視系 Digital X-ray Radiography Fluoroscopy System、數字化醫用X射線攝影系統Digital Medical X-ray Radiography System、數字化攝影X射線系統 Digital Radiography X-ray System [Luminos Agile Max, Luminos dRF Max, Ysio Max, YSIO X.pree, Ysio] (Chinese Only) |
|
| 07 Sep 2023 |
醫療儀器安全警示: 美國美敦力施美敦股份有限公司 Medtronic Xomed,lnc 手術動力系統 Integrated Power Console System (Chinese Only) |
|
| 06 Sep 2023 |
Medical Device Safety Alert: St. Jude Medical TactiSys Quartz PN-004 400 |
|
| 31 Aug 2023 |
Medical Device Safety Alert: Medtronic Palindrome Chronic Catheter Kit - 14.5 Fr/Ch (4.8 mm) x 23 cm |
|
| 31 Aug 2023 |
Medical Device Safety Alert: Philips Medical Systems Nederland B.V. Wired Foot Switch |
|
| 31 Aug 2023 |
Medical Device Safety Alert: Abbott Medical Apical Coring Knife and HeartMate 3 LVAD Kits [Models: 1050, 106524INT; GTIN: 00813024010227, 00813024011712] |
|
| 30 Aug 2023 |
醫療儀器安全警示: 強生國際歐洲物流中心Johnson & Johnson International c/o European Logistics Centre 合成可吸收性外科縫線 VICRYL Polyglactin 910 Braided Synthetic Absorbable Suture (Chinese Only) |
|
| 28 Aug 2023 |
Medical Device Safety Alert: HeartWare Inc HeartWare Ventricular Assist Device (HVAD) Systems [Product Code: 1104] |
|
| 28 Aug 2023 |
Medical Device Safety Alert: Depuy (Ireland) Attune Cementless CR Femur |
|
| 24 Aug 2023 |
Medical Device Safety Alert: Boston Scientific Corporation EMBLEM S-ICD Pulse Generator |
|
| 22 Aug 2023 |
Medical Device Safety Alert: Philips Medical Systems Nederland B.V. Multidiagnost Eleva, Allura Xper and Azurion systems |
|
| 22 Aug 2023 |
Medical Device Safety Alert: GE Medical Systems Information Technologies Inc. Prucka 3 Amplifiers, Field Replaceable Units (FRUs) used with CardioLab AltiX and ComboLab AltiX (Update) |
|
| 21 Aug 2023 |
Medical Device Safety Alert: Philips Healthcare (Suzhou) Co., Ltd. Philips Incisive CT and CT 3500 Systems |
|
| 21 Aug 2023 |
Medical Device Safety Alert: Berlin Heart GmbH Excor System Cannulas |
|
| 21 Aug 2023 |
Medical Device Safety Alert: St. Jude Medical Cardiac Rhythm Management Division The Gallant, Entrant, and Neutrino NxT HV Devices |
|
| 21 Aug 2023 |
Medical Device Safety Alert: Philips Medical Systems Nederland B.V. Philips Spectral CT7500 |
|
| 21 Aug 2023 |
Medical Device Safety Alert: Medtronic Neurosurgery Medtronic REF 46915 Duet External Drainage and Monitoring System |
|
| 17 Aug 2023 |
Medical Device Safety Alert: W.O.M. World of Medicine Gmbh Stryker Endoscopy Devices |
|
| 16 Aug 2023 |
Medical Device Safety Alert: Optikgerate GmbH Pentacam AXL (Type 70100) and Pentacam AXL Wave (Type 70020) |
|
| 15 Aug 2023 |
Medical Device Safety Alert: B. Braun Infusomat Space |
|
| 15 Aug 2023 |
Medical Device Safety Alert: AMBU Australia Pty Ltd aView 2 Advance |
|
| 09 Aug 2023 |
Medical Device Safety Alert: Hamilton Medical AG HAMILTON-C1/T1/MR1 Ventilators [Product Codes: 161001, 161006, 161009, 161010] (Update) |
|
| 08 Aug 2023 |
Medical Device Safety Alert: Medtronic Inc Model A610 DBS Clinician Programmer Application [Serial # R32J2004Z6F] |
|
| 04 Aug 2023 |
Medical Device Safety Alert: Ethicon PDS II (polydioxanone) Suture and PDS Plus Antibacterial (polydioxanone) Suture |
|
| 04 Aug 2023 |
Medical Device Safety Alert: Baxter Healthcare EVO IQ Large Volumetric Pumps |
|
| 04 Aug 2023 |
Medical Device Safety Alert: 美國捷邁公司Zimmer Inc. 股骨柄 Femoral Stem (Chinese Only) |
|
| 31 Jul 2023 |
Medical Device Safety Alert: Abbott Medical Proclaim, Infinity Implantable Pulse Generators and Clinician Programmer Application and Patient Controller Application |
|
| 27 Jul 2023 |
Medical Device Safety Alert: Philips Medical Systems Nederland BV Philips Spectral CT7500 |
|
| 26 Jul 2023 |
Medical Device Safety Alert: NVT GmbH ALLEGRA Transcatheter Heart Valve (ALLEGRA THV 23) [Ref.: THV-AO0023G1RE] |
|
| 24 Jul 2023 |
Medical Device Safety Alert: Siemens Philips 3D9-3v Transducer |
|
| 24 Jul 2023 |
Medical Device Safety Alert: Siemens Medical Solutions USA Inc ACUSON Redwood 2.0 ultrasound systems - 18L6 transducer |
|
| 19 Jul 2023 |
Medical Device Safety Alert: Siemens Medical Solutions USA, Inc. Symbia Pro.specta [Product codes: 11364751, 11364752 and 11364753] |
|
| 18 Jul 2023 |
Medical Device Safety Alert: Alcon Laboratories Alcon Phaco Tips and packs or kits containing |
|
| 11 Jul 2023 |
Medical Device Safety Alert: Respironics Inc. Also Trading As Philips Rs North America LLC Philips BiPAP and Humidifiers |
|
| 10 Jul 2023 |
Medical Device Safety Alert: Zimmer, Inc. NexGen Precoat Stemmed Tibial Plate |
|
| 10 Jul 2023 |
Medical Device Safety Alert: Beckman Coulter Inc Access Folate and Access TSH Reagent Packs when used on DxI 9000 Access Immunoassay Analyser |
|
| 10 Jul 2023 |
Medical Device Safety Alert: Olympus Medical Systems Corporation Bronchoscopes, Tracheal Intubation Scopes and Airway Mobile-Scopes |
|
| 05 Jul 2023 |
Medical Device Safety Alert: Philips Allura Xper and Azurion systems |
|
| 04 Jul 2023 |
Medical Device Safety Alert: Zimmer Biomet Zimmer Periarticular Locking Plate System, Distal Lateral Femoral Plate Right 6 Holes 159mm Length |
|
| 04 Jul 2023 |
Medical Device Safety Alert: Johnson & Johnson Vision TECNIS Symfony IOLs (ZXR00) and TECNIS Eyhance IOLs (ICB00) |
|
| 03 Jul 2023 |
Medical Device Safety Alert: Olympus Intestinal Videoscope Psf-1, Single Use Powerspiral Tube Dpst-1 and Powerspiral Control Unit Pscu |
|
| 03 Jul 2023 |
Medical Device Safety Alert: Abiomed Inc. Impella Cp and Impella Cp with Smart Assist |
|
| 03 Jul 2023 |
Medical Device Safety Alert: Hamilton Medical AG Hamilton C1, T1, MR1 Ventilators |
|
| 30 Jun 2023 |
Medical Device Safety Alert: Philips Spectral CT 7500 |
|
| 27 Jun 2023 |
Medical Device Safety Alert: Olympus Winter & Ibe GmbH/ HF-Resection Electrode [Multiple Model Numbers] |
|
| 26 Jun 2023 |
Medical Device Safety Alert: Heartware, Inc. HeartWare Ventricular Assist Device System |
|
| 26 Jun 2023 |
Medical Device Safety Alert: Philips Intellivue MX40 Patient Monitor |
|
| 26 Jun 2023 |
Medical Device Safety Alert: GE Vingmed Ultrasound A/S Vivid S60 / Vivid S70 / Vivid S60N / Vivid S70N Ultrasound Systems |
|
| 26 Jun 2023 |
Medical Device Safety Alert: Siemens Healthcare GmbH ARTIS pheno, ARTIS icono biplane, ARTIS icono floor |
|
| 23 Jun 2023 |
Medical Device Safety Alert: SenTec AG V-Sign Sensor 2 |
|
| 23 Jun 2023 |
Medical Device Safety Alert: Hamilton Medical AG Hamilton-C2/C3/C1/T1 ventilators |
|
| 21 Jun 2023 |
Medical Device Safety Alert: Philips Medical Systems Nederland BV Philips Big Bore RT, Brilliance CT Big Bore and Brilliance CT Big Bore Oncology (software version 4.8.0) |
|
| 21 Jun 2023 |
Medical Device Safety Alert: Philips Medical Systems PageWriter TC30/50/70 Cardiographs |
|
| 16 Jun 2023 |
Medical Device Safety Alert: Megadyne Medical Products, Inc. MEGADYNE Suction Coagulators |
|
| 16 Jun 2023 |
Medical Device Safety Alert: Philips Spectral CT 7500 |
|
| 16 Jun 2023 |
Medical Device Safety Alert: GE OEC Medical Systems Inc. GE OEC Elite and OEC Mobile Elite C-Arms General Surgical Platform Non-Motorized Cooling |
|
| 16 Jun 2023 |
Medical Device Safety Alert: Epocal Inc. EPOC Blood Analysis BGEM Test Cards, EPOC Blood Analysis System - Single Use Blood Gas, Electrolyte and Metabolite Test Card |
|
| 15 Jun 2023 |
Medical Device Safety Alert: Olympus BF series bronchoscopes |
|
| 09 Jun 2023 |
Medical Device Safety Alert: MEGADYNE MEGA SOFT Universal and Universal Plus Reusable Patient Return Electrodes |
|
| 09 Jun 2023 |
Medical Device Safety Alert: GE Healthcare Australia Pty Ltd. Giraffe OmniBeds and Giraffe OmniBed Carestation |
|
| 09 Jun 2023 |
Medical Device Safety Alert: Philips Electronics. Azurion and Allura Xper series |
|
| 09 Jun 2023 |
Medical Device Safety Alert: Beckman Coulter Inc Coulter DxH Diluent |
|
| 09 Jun 2023 |
Medical Device Safety Alert: Siemens Healthcare GmbH Mobilett Mira Max |
|
| 07 Jun 2023 |
Medical Device Safety Alert: Löwenstein Medical Technology Ventilators of the LUISA, TIVAN LS, Life One (LM150TD) series |
|
| 02 Jun 2023 |
Medical Device Safety Alert: Stryker Spine Ogival Interbody Cage, PEEK |
|
| 02 Jun 2023 |
Medical Device Safety Alert: BioFire Diagnostics, LLC BioFire Respiratory Panel 2.1 (Rp2.1) |
|
| 29 May 2023 |
Medical Device Safety Alert: Berlin Heart GmbH EXCOR Pediatric Ventricular Assist Device Blood Pumps |
|
| 29 May 2023 |
Medical Device Safety Alert: Philips Medical Systems Nederland B.V. Philips IQon, iCT, Ingenuity and Brilliance CT 64 systems |
|
| 25 May 2023 |
Medical Device Safety Alert: Siemens Medical Solutions USA, Inc Luminos Agile Max, Luminos dRF Max, LUMINOS Lotus Max |
|
| 24 May 2023 |
Medical Device Safety Alert: Dragerwerk AG & Co. KGaA Oxylog 3000 plus |
|
| 23 May 2023 |
Medical Device Safety Alert: Bio-Rad Geenius HIV 1/2 Confirmatory Assay |
|
| 19 May 2023 |
Medical Device Safety Alert: Beckman Coulter Inc Access Hybritech p2PSA assay. An in vitro diagnostic medical device (IVD) |
|
| 18 May 2023 |
Medical Device Safety Alert: Philips North America ProxiDiagnost N90 R.1.0 and CombiDiagnost R90 R.1.0, R1.1 |
|
| 17 May 2023 |
Medical Device Safety Alert: Abiomed, Inc. Impella 5.5 with SmartAssist heart pump |
|
| 15 May 2023 |
Medical Device Safety Alert: NOxBOX Ltd. NOxBOXi Nitric Oxide Delivery Device [NOXBOX-I, UDI-DI: (01)05060541640009] |
|
| 12 May 2023 |
Medical Device Safety Alert: BioFire Diagnostics LLC BIOFIRE FILMARRAY Gastrointestinal (GI) Panel Pouch Module |
|
| 12 May 2023 |
Medical Device Safety Alert: Philips Healthcare (Suzhou) Co., Ltd Incisive CT |
|
| 11 May 2023 |
Medical Device Safety Alert: Siemens Mammomat Revelation |
|
| 08 May 2023 |
Medical Device Safety Alert: Philips Incisive CT & CT 3500 System |
|
| 08 May 2023 |
Medical Device Safety Alert: Depuy Ireland Uc, Cemvac System - Nozzles |
|
| 04 May 2023 |
Medical Device Safety Alert: Becton Dickinson Ventralight ST Mesh with Echo PS Positioning System |
|
| 04 May 2023 |
Medical Device Safety Alert: GE Healthcare Centricity PACS-IW with Universal Viewer, Centricity Universal Viewer and Centricity PACS-IW |
|
| 02 May 2023 |
Medical Device Safety Alert: Thermo Fisher Scientific Phadia 200 |
|
| 20 Apr 2023 |
Medical Device Safety Alert: Mobius Imaging LLC Airo TruCT Mobile CT Scanner |
|
| 17 Apr 2023 |
Medical Device Safety Alert: BioFire Diagnostics, FilmArray Gastrointestinal (GI) Panel for FILMARRAY Systems |
|
| 17 Apr 2023 |
Medical Device Safety Alert: Cook, Inc. Blue Rhino G2 Multi Percutaneous Tracheostomy Introducer Set and Tray |
|
| 14 Apr 2023 |
Medical Device Safety Alert: Covidien Step Bladeless Trocars, Chromic Gut Absorbable Sutures, Mild Chromic Gut Absorbable Suture, and Plain Gut Absorbable Sutures |
|
| 12 Apr 2023 |
Medical Device Safety Alert: Huntleigh Healthcare Ltd TEAM3A & TEAM3I Fetal Monitor |
|
| 11 Apr 2023 |
Medical Device Safety Alert: Solta Medical Inc THERMAGE CPT SYSTEM [Model number: TG-2B, UDI-DI Code: 00850608002124, Serial Number: 001933] |
|
| 06 Apr 2023 |
Medical Device Safety Alert: Instrumentation Laboratory Company (a Werfen Company) HemoslL Liquid Anti-Xa (Part Number: 0020302600 and 0020302601) |
|
| 06 Apr 2023 |
Medical Device Safety Alert: Philips Medical Systems Nederland B.V. Ingenia Elition X, Ingenia Elition S, SmartPath to Ingenia Elition X, MR 7700 and 'Upgrade to MR 7700' |
|
| 06 Apr 2023 |
Medical Device Safety Alert: Cook Medical Europe Ltd. Advance Micro 14 Ultra Low-Profile PTA Balloon Catheter and Ultrathane Cook-Cope Type Locking Loop Multipurpose Drainage Catheter |
|
| 03 Apr 2023 |
Medical Device Safety Alert: Philips EarlyVue VS30 Vital Signs Monitor and EarlyVue VS30 Vitals monitor |
|
| 03 Apr 2023 |
Medical Device Safety Alert: Philips Medical Systems Nederland B.V. Philips Azurion System |
|
| 31 Mar 2023 |
Medical Device Safety Alert: Medtronic Covidien Shiley Adult Flexible Tracheostomy Tube with TaperGuard Cuff, and Cuffless: Disposable Inner Cannula or Reusable Inner Cannula |
|
| 30 Mar 2023 |
Medical Device Safety Alert: Philips Spectral CT 7500 |
|
| 30 Mar 2023 |
Medical Device Safety Alert: Beckman Coulter, Inc. Access System Free T3 Assays |
|
| 30 Mar 2023 |
Medical Device Safety Alert: Medical Device Safety Alert: Philips Healthcare (Suzhou) Co., Ltd. Incisive CT |
|
| 29 Mar 2023 |
Medical Device Safety Alert: Cordis Corporation ANGIOGUARD RX Emboli Capture Guidewire System |
|
| 27 Mar 2023 |
Medical Device Safety Alert: CooperVision, Inc. Clariti 1-day toric soft contact lenses, Power -1.00 -1.25/90 |
|
| 23 Mar 2023 |
Medical Device Safety Alert: Iradimed Corporation MRidium 1057 MRI Syringe Adapter Set |
|
| 20 Mar 2023 |
Medical Device Safety Alert: GE Vingmed Ultrasound A/S, Vscan Air CL |
|
| 20 Mar 2023 |
Medical Device Safety Alert: Philips Healthcare (Suzhou) Co., Ltd. DigitalDiagnost C50 System |
|
| 17 Mar 2023 |
Medical Device Safety Alert: B Braun Medical Ltd Caiman Maryland Non Articulat, Caiman Maryland Articulating |
|
| 17 Mar 2023 |
Medical Device Safety Alert: BioFire Diagnostics, LLC In Vitro Diagnostic (IVD) Panel BioFire BCID2 Panel, Panel BioFire Respiratory Panel 2.1 (RP2.1), Panel FilmArray GI Panel |
|
| 13 Mar 2023 |
Medical Device Safety Alert: Synthes (USA) Products LLC TFN-Advanced Femoral Nail |
|
| 10 Mar 2023 |
Medical Device Safety Alert: Philips DigitalDiagnost, ProxiDiagnost and CombiDiagnost systems |
|
| 10 Mar 2023 |
Medical Device Safety Alert: Philips Prodiva 1.5T and Ingenia LS MR Systems |
|
| 10 Mar 2023 |
Medical Device Safety Alert: Bard Peripheral Vascular Inc Trading as CR Bard Inc Mission Kit 16G x 10CM and Mission Kit 18G x 16CM |
|
| 09 Mar 2023 |
Medical Device Safety Alert: Terumo Blood and Cell Technologies APC-30 PROCEDURE PACK |
|
| 09 Mar 2023 |
Medical Device Safety Alert: Depuy (Ireland) Attune System - Tibial Insert Fixed Bearing Posterior Stabilized |
|
| 07 Mar 2023 |
Medical Device Safety Alert: Intuitive Surgical Inc ASSY, USM, IS4000 da Vinci Xi Surgical System and da Vinci X Surgical Systems |
|
| 02 Mar 2023 |
Medical Device Safety Alert: Davol Inc Subsidiary of C R Bard Inc PerFix Plug, PerFix Light Plug, Ventralex Hernia Patch and Bard Mesh |
|
| 01 Mar 2023 |
Medical Device Safety Alert: William A. Cook Australia, Pty. Ltd. Zenith Branch Endovascular Graft -Iliac Bifurcation |
|
| 01 Mar 2023 |
Medical Device Safety Alert: Philips IntelliVue G7m Anesthesia Gas Modules |
|
| 01 Mar 2023 |
Medical Device Safety Alert: NIDEK Preloaded SZ-1/ SZ-1C IOLs |
|
| 28 Feb 2023 |
Medical Device Safety Alert: RaySearch Laboratories RayStation, RayPlan 9A, 9B, 10A, 10B, 11A, 11B including service packs |
|
| 28 Feb 2023 |
Medical Device Safety Alert: Hamilton Medical AG HAMILTON-C6 Ventilator |
|
| 17 Feb 2023 |
Medical Device Safety Alert: Philips Healthcare (Suzhou) Co., Ltd Incisive CT system [Software version: 5.0; Reference numbers: 728143, 728144, 728149, 728146, 728148 & 728151] |
|
| 09 Feb 2023 |
Medical Device Safety Alert: CooperVision Clariti 1 Day Toric Contact Lenses |
|
| 08 Feb 2023 |
Medical Device Safety Alert: BD Insulin Syringes with Needle |
|
| 17 Jan 2023 |
Medical Device Safety Alert:Siemens Healthineers SOMATOM go.Top/ x.cite |
|
| 13 Jan 2023 |
Medical Device Safety Alert: B. Braun Melsungen AG Original Perfusor Line |
|
| 10 Jan 2023 |
Medical Device Safety Alert: Bard Peripheral Vascular, Inc. Catheter Repair Kits |
|
| 04 Jan 2023 |
Medical Device Safety Alert: Siemens Healthcare Gmbh Magnetom Systems |
|
| 23 Dec 2022 |
Medical Device Safety Alert: Mobius Imaging Airo Mobile Ct System |
|
| 22 Dec 2022 |
Medical Device Safety Alert: Siemens Healthcare GmbH ARTIS icono / pheno system in combination with a Siemens Healthineers VE OR Table |
|
| 22 Dec 2022 |
Medical Device Safety Alert: GE Healthcare Nuclear Medicine 600/800 Series systems |
|
| 19 Dec 2022 |
Medical Device Safety Alert: DePuy International Limited T/A DePuy CMW BIOSTOP G Bioresorbable Cement Restrictor |
|
| 15 Dec 2022 |
Medical Device Safety Alert: Philips Medical Systems DMC GmbH ProxiDiagnost N90 1.1 |
|
| 15 Dec 2022 |
Medical Device Safety Alert: Siemens Healthcare AXIOM Luminos TF, AXIOM Iconos R100 and R200, AXIOM Luminos Agile, Luminos Agile Max, AXIOM Luminos dRF, Luminos dRF Max and LUMINOS Lotus Max systems |
|
| 14 Dec 2022 |
Medical Device Safety Alert: Covidien LLC Medtronic Nonabsorbable Sutures |
|
| 06 Dec 2022 |
Medical Device Safety Alert: GE Healthcare Centricity Universal Viewer Zero Footprint Client |
|
| 30 Nov 2022 |
Medical Device Safety Alert: Philips Respironics SimplyGo portable oxygen concentrator and the Repair Kit |
|
| 28 Nov 2022 |
Medical Device Safety Alert: Philips Ingenia Elition X, Ingenia Elition S, SmartPath to Ingenia Elition X, MR 7700 and ‘Upgrade to MR 7700’ |
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| 28 Nov 2022 |
Medical Device Safety Alert: Siemens Healthcare GmbH Sensis, Sensis Vibe Hemo, Sensis Vibe Combo with VD12A software |
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| 22 Nov 2022 |
Medical Device Safety Alert: Arrow International LLC Arrow AutoCAT Intra-Aortic Balloon Pump (IABP) Series; AC3 Series IABP System |
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| 21 Nov 2022 |
Medical Device Safety Alert: Hamilton Medical AG Hamilton-C6 |
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| 16 Nov 2022 |
Medical Device Safety Alert: Olympus Medical Systems Corporation Endoeye Flex 3D Deflectable Videoscope [LTF-190-10-3D] |
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| 16 Nov 2022 |
Medical Device Safety Alert: Siemens Healthcare Syngo.via |
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| 14 Nov 2022 |
Medical Device Safety Alert: Philips Healthcare Philips Incisive CT PIM |
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| 02 Nov 2022 |
Medical Device Safety Alert: Philips Respironics Sleep & Respiratory Care Devices |
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| 26 Oct 2022 |
Medical Device Safety Alert: BALT USA, LLC Optima Coil System |
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| 05 Oct 2022 |
Medical Device Safety Alert: GE Medical Systems 9100c NXT and Aelite NXT anesthesia devices |
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| 19 Sep 2022 |
Philips LeMaitre Vascular Inc Syntel Silicone Over the Wire Embolectomy Catheter |
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| 25 Aug 2022 |
Philips SmartPath to dStream and Ingenia systems |
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| 17 Aug 2022 |
Medical Device Safety Alert: GE Healthcare Service manuals for the CT, PET, or NM table |
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| 10 Aug 2022 |
Medical Device Safety Alert: Medtronic Medline Sprinter OTW |
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| 03 Aug 2022 |
Medical Device Safety Alert: Datex-Ohmeda, Inc. Aisys CS2, Avance CS2 and Avance CS2 Pro Anesthesia System. |
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| 15 Jul 2022 |
Medical Device Safety Alert: Medtronic, Inc. EverFlex Self-Expanding Peripheral Stent with Entrust Delivery System |
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| 14 Jul 2022 |
Medical Device Safety Alert: Philips Medical Systems Philips Efficia CMS200 Central Monitoring Station and the Efficia CM100, CM10, CM120, CM12 and CM150 |
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| 14 Jul 2022 |
Medical Device Safety Alert: Siemens Healthcare Gmbh Magnetom Aera, Magnetom Prisma, Magnetom Prisma Fit, Magnetom Skyra |
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| 30 Jun 2022 |
Medical Device Safety Alert: Medtronic HeartWare HeartWare Ventricular Assist Device (HVAD) System Battery |
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| 23 Jun 2022 |
Medical Device Safety Alert: Medtronic Inc. Cobalt XT, Cobalt and Crome Implantable Cardioverter Defibrillators (ICDs) and Cardiac Resynchronization Therapy Defibrillators (CRT-Ds) |
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| 22 Jun 2022 |
Medical Device Safety Alert: Siemens Healthcare GmbH Sensis and Sensis Vibe Combo systems |
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| 10 Jun 2022 |
Medical Device Safety Alert: Medtronic Palindrome Precision Chronic Hemodialysis Catheters, Palindrome Chronic Hemodialysis Catheters, Mahurkar Chronic Carbothane Catheters |
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| 10 Jun 2022 |
Medical Device Safety Alert: GE Healthcare Centricity Universal Viewer Zero Footprint Client |
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| 06 Jun 2022 |
Medical Device Safety Alert: Siemens Healthcare GmbH ARTIS icono biplane |
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| 31 May 2022 |
Medical Device Safety Alert: ZELTIQ Aesthetics, Inc. ZELTIQ Cryolipolysis Skin Contouring System |
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| 31 May 2022 |
Medical Device Safety Alert: Medtronic MiniMed 600 and 700 Series Insulin Pump Battery Cap |
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| 24 May 2022 |
Medical Device Safety Alert: Abbott Vascular Absolute Pro LL Peripheral Self-Expanding Stent System |
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| 20 May 2022 |
Medical Device Safety Alert: GE Medical Systems information Technologies CARESCAPE Central Station V2 units |
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| 16 May 2022 |
Medical Device Safety Alert: Hunan Accurate Bio-Medical Technology, Pulse Oximeter (FS20D) |
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| 06 May 2022 |
Medical Device Safety Alert: Datex-Ohmeda Avance CS2 and Avance CS2 Pro anesthesia devices |
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| 05 May 2022 |
Medical Device Safety Alert: Philips Healthcare Incisive CT |
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| 04 May 2022 |
Medical Device Safety Alert: Siemens Healthcare GmbH syngo.via RT Image Suite upgraded to VB60 |
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| 26 Apr 2022 |
Medical Device Safety Alert: Philips Medical Systems Nederland B.V. Ingenia Elition X, Ingenia Elition S |
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| 13 Apr 2022 |
Medical Device Safety Alert: Medtronic Inc. Cobalt and Crome Implantable Cardioverter Defibrillators (ICDs) and Cardiac Resynchronization Therapy Defibrillators (CRT-Ds) |
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| 06 Apr 2022 |
Medical Device Safety Alert: Medtronic Puritan Bennett 980 Series Ventilator |
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| 23 Mar 2022 |
Medical Device Safety Alert: Medtronic, Inc. IN.PACT Admiral Paclitaxel-coated PTA Balloon Catheter |
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| 23 Mar 2022 |
Medical Device Safety Alert: Baxter Healthcare PrisMax System |
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| 17 Mar 2022 |
Medical Device Safety Alert: GE Medical Systems Signa & Discovery MR |
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| 03 Mar 2022 |
Medical Device Safety Alert: Siemens Healthcare GmbH Artis Zee, Zeego, Q, Q.zen Systems |
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| 28 Feb 2022 |
Medical Device Safety Alert: RaySearch Laboratories AB (publ) RayStation 4-11B, and RayPlan 1, 2, 7-11B including some service packs. |
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| 23 Feb 2022 |
Medical Device Safety Alert: Siemens Healthcare GmbH ARTIS icono biplane, ARTIS icono floor and ARTIS pheno |
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| 23 Feb 2022 |
Medical Device Safety Alert: Siemens Healthcare GmbH Artis systems with syngo Application Software version VE20 |
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| 09 Feb 2022 |
Medical Device Safety Alert: Medtronic MiniMed 600 and 700 series insulin pump |
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| 28 Jan 2022 |
Medical Device Safety Alert: Medtronic HeartWare HeartWare Ventricular Assist Device (HVAD) |
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| 26 Jan 2022 |
Medical Device Safety Alert: Acandis GmbH DERIVO 2 Embolisation Device |
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| 19 Jan 2022 |
Medical Device Safety Alert: Philips Medical Systems, ST80i Stress Test System |
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| 18 Jan 2022 |
Medical Device Safety Alert: Baxter Healthcare Ltd Transfer Set (MiniCap Extended Life PD Transfer Set (6") with Twist Clamp) [Product Code: 5C4482] |
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| 17 Jan 2022 |
Medical Device Safety Alert: RaySearch Laboratories AB (publ) RayStation/RayPlan 6, 7, 8A, 8B, 9A, 9B including some service packs |
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| 17 Jan 2022 |
Medical Device Safety Alert: GE Medical Systems All GE Healthcare MRI systems with superconducting magnets [Update] |
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| 14 Jan 2022 |
Medical Device Safety Alert: GE Medical Systems All GE Healthcare MRI systems with superconducting magnets |
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