Starting from 1 January 2022, active safety alerts related to medical devices listed under MDACS are listed below. For safety alerts before 1 January 2022, please refer to archive.
The United States Food and Drug Administration (FDA) has posted a medical device safety alert concerning the following devices manufactured by Philips Medical Systems DMC GmbH:
- CombiDiagnost R90, Radiography and Fluoroscopy (R/F) system [Model No. 709030 and 709031]
- DigitalDiagnost 4 Chest/Emergency [Model No. 712029 & 712033] [HKMD No.: 100258]
- DigitalDiagnost 4 Flex/Value [Model No. 712028, 712227, & 712032] [HKMD No.: 100258]
- DigitalDiagnost 4 High Performance [Model No. 712027, 712031 & 712226] [HKMD No.: 100258]
- DigitalDiagnost C90 Flex/Value/Chest/ER [Model No. 712035] [HKMD No.: 100258]
- DigitalDiagnost C90 High Performance [Model No. 712034] [HKMD No.: 100258]
- DigitalDiagnost C90 Release 3 [Model No. 712025] [HKMD No.: 100258]
- DigitalDiagnost C90 Release 3.1 [Model No. 712026] [HKMD No.: 100258]
- EasyDiagnost Eleva DRF, Release 5 [Model No. 706050]
- ProxiDiagnost N90 [Model No. 706100 & 706110] [HKMD No.: 210062]
According to the FDA, there is a potential for units suspended on the ceiling to fail and fall.
For further information, please visit https://www.accessdata.fda.gov/scripts/ires/index.cfm?Event=93200
If you are in possession of the affected products, please contact your supplier for necessary actions.
Posted on 10 Nov 2023