Recall Z-1256-2022 ยท MEC Disinfector, Medical Devices
Steris Corporation
Reliance Synergy Washer/Disinfector
| Date | Apr 22, 2022 |
| Status | Terminated |
| Reason | The firm identified that when the electrical contactor component in the drying chamber of the Washer/Disinfector malfunctions, the heating elements in the drying chamber could overheat, eventually resulting in smoke and/or fire. |
| Root cause | Component design/selection |
| Action | On April 22, 2022, the firm distributed notification letters to affected customers. All affected customers will be contacted by a STERIS Service Technician to arrange an onsite inspection of their unit(s) and perform the correction. Users may continue to use their affected devices prior to completion of the correction. Users are reminded to follow instructions outlined in the Operator Manual should the unit alarm "Drying Temperature Too High" by aborting the cycle, positioning building electrical disconnect switch to OFF, and contacting STERIS. If you have questions regarding this issue, plea |
| Quantity | 3,863 total units (2,776 US; 1,087 OUS) |
| Distribution | Worldwide distribution - US Nationwide. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.