Recall Z-0876-2021 ยท MEC Disinfector, Medical Devices
Steris Corporation
Reliance Vision Single-Chamber Washer/Disinfector - Product Usage: intended for use in the cleaning and intermediate level disinfection of soiled reusable utensils, trays, glassware, bedpans and urinals, rubber and plastic goods, simple hard-surfaced rigid surgical instruments, such as forceps and clamps, theatre shoes, and other similar and related articles found in healthcare facilities.
| Date | Dec 11, 2020 |
| Status | Terminated |
| Reason | The electrical contactor component present in the drying chamber of the Reliance Vision Single-Chamber Washer/Disinfector may malfunction, potentially leading to the heating elements in the drying chamber to overheat, eventually resulting in smoke and/or fire. |
| Root cause | Component design/selection |
| Action | On December 11, 2020, the firm distributed Urgent Medical Device Correction letters to customers. The letter informed customers that heating elements in the drying chamber may overheat, eventually resulting in smoke and/or fire. The firm has developed an automatic shut off of the power to prevent the heating elements from overheating if this malfunction were to occur. The unit would remain "ON" in an alarm state, informing the user that service is required. All affected customers will be contacted by a STERIS service technician to arrange an onsite inspection of their unit(s) and perform the |
| Quantity | 3405 |
| Distribution | Worldwide distribution - US Nationwide distribution and the countries of Australia, Belgium, Brazil, Bulgaria, Canada, Chile, China, Ecuador, France, Germany, Hong Kong, Ireland, Israel, Italy, Japan, Korea, Republic of Malaysia, Mexico, New Zealand, Panama, Portugal, Russian Federation, Saudi Ara |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.