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.
Medical device manufacturer, Advanced Sterilization Products, Inc., has issued a medical device safety alert concerning STERRAD 100NX Sterilizers and STERRAD NX Sterilizers [Product Codes: STERRAD 100NX Sterilizer (10104, 10104-002, 10104-003, 10104-004); STERRAD 100NX Sterilizer with ALLClear Technology (10104-005, 10104-006, 10104-007, 10104-008); STERRAD NX Sterilization System (10033, 10033-002); STERRAD NX Sterilization System with ALLClear Technology (10033-004)] [HKMD No.: 210461, 220154].
The manufacturer has determined that certain STERRAD 100NX Sterilizers and STERRAD NX Sterilizers (hereinafter “STERRAD Sterilization Systems” or “sterilization system”), manufactured after Sep 2019, contain a UV lamp power supply that may experience a short circuit, causing the power supply to fail. If this short circuit condition occurs, the sterilization system will be unable to detect the UV light and the system will not start the sterilization cycle. If the short circuit occurs during a sterilization cycle, the cycle will cancel and display a cancelation message. In 0.37% of these identified sterilization systems, a power supply failure leading to overheating has occurred, and in 0.15% of the overheating occurrences there were reports of the sterilizer emitting an electrical burning odor and smoke was visible.
The manufacturer advises affected users that if an odor or smoke is observed, power off the unit and contact the manufacturer for service. The manufacturer is implementing a correction to eliminate the possibility of overheating and the potential for burning odor and smoke and will service impacted STERRAD Sterilization Systems during the next service calls starting in Nov 2023.
If you are in possession of the affected products, please contact your supplier for necessary actions.
Posted on 29 Nov 2023