Recall Z-1941-2010 ยท FQO Table, Operating-Room, Ac-Powered
Steris Corporation
STERIS 4085, 5085 & 5085SRT Surgical Tables
| Date | Jun 30, 2010 (initiated May 14, 2010) |
| Status | Terminated |
| Reason | STERIS has learned that a limited quantity of manifold assemblies were manufactured by our supplier with incorrect washers and springs in the valves of the manifold. This supplier error has the potential to cause: a) an inability to articulate/move a table section when commanded by the operator; b) two different articulations occurring when a single articulation is commanded, or c) that the table |
| Root cause | Nonconforming Material/Component |
| Action | On May 14, 2010 the firm sent FCL letters to their customers notifying them of the problem. They informed their customers that a service representative will contact them to arrange correction of the unit. |
| Quantity | 79 units |
| Distribution | Worldwide distribution: USA, Australia, India, Korea & New Zealand |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K090136 | STERIS CMAX XLT SURGICAL TABLE STERIS Corporation, Mar 20, 2009 |