Recall Z-1595-2023 ยท MEC Disinfector, Medical Devices
Steris Corporation
Reliance Vision Multi-Chamber Washer/Disinfector, Reference Number FH83062
| Date | May 17, 2023 (initiated Apr 10, 2023) |
| Status | Open, Classified |
| Reason | In the remote occurrence in which the electrical contactor component present in the drying chambers of the Reliance Vision Multi-Chamber Washer/Disinfector malfunctions, the heating elements in the drying chamber could overheat, eventually resulting in smoke and/or fire. |
| Root cause | Nonconforming Material/Component |
| Action | An URGENT MEDICAL DEVICE FIELD CORRECTION dated 3/28/23 was sent to customers. STERIS Action: All affected Customers will be contacted by a STERIS Service Technician to arrange an onsite inspection of their unit(s) to perform the correction. User Action: Users can continue to use their Reliance Vision Multi-Chamber Washer/Disinfector prior to completion of the correction. Should your unit alarm Drying Temperature Too High, abort the cycle, turn off the power to the unit, and contact STERIS. The competent (regulatory) authority of your country has been informed of this notice. Customer res |
| Quantity | 322 units |
| Distribution | Worldwide Distribution: US (Nationwide) and OUS (Foreign) to countries of: China, Lithuania, Saudi Arabia, Korea, Republic of, Canada, Taiwan, United Kingdom, Spain, Australia, New Zealand, Spain, Brazil, Bahrain, Switzerland, Great Britain, South Africa, Hong Kong, Qatar. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.