Recall Z-0279-2012 ยท FQO Table, Operating-Room, Ac-Powered
Steris Corporation
STERIS 5085 and 5085SRT Surgical Tables, Catalog Numbers: 5085- ST01-410-1; 5085SRT- ST0-1420-6.
| Date | Nov 23, 2011 (initiated Oct 17, 2011) |
| Status | Terminated |
| Reason | Some hydraulic column cylinders installed in certain 5085 and 5085SRT Surgical Tables were assembled by their supplier with incorrect snap rings and an anomaly was present in the tilt cylinder. This error may affect the user's ability to move the table top out of the full right tilt position. |
| Root cause | Nonconforming Material/Component |
| Action | On October 17, 2011, Steris sent 'Urgent Voluntary Field Correction Notices' to their customers via Fedex with tracking numbers for delivery confirmation. The letter identifies the affected product and notifies the user/customers of the problem with the surgical tables. The notification letter goes on to inform the customers that a STERIS Service Representative will be contacting them to arrange for the field correction of the affected unit(s). This involves the replacement of the hydraulic column cylinder of each surgical table(s). |
| Quantity | 167 tables were distributed - 5085=108 and 5085SRT=59 |
| Distribution | Nationwide distribution. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K090136 | STERIS CMAX XLT SURGICAL TABLE STERIS Corporation, Mar 20, 2009 |