Recall Z-1605-2010 ยท BRY Cabinet, Table And Tray, Anesthesia
Stryker Communications Corp
Universal Flat Panel Yoke, a component of the Stryker Flat Panel Arm. The yoke is intended to hold a flat panel monitor.
| Date | May 14, 2010 (initiated Apr 7, 2010) |
| Status | Terminated |
| Reason | Some of the pitch shafts were not properly welded which results in the monitor becoming unlevel. |
| Root cause | Nonconforming Material/Component |
| Action | An Urgent: Medical Device Recall letter dated April 19, 2010 was sent to customers. It was recommended that customers continue use of the product unless the monitor becomes unlevel. The customer was notified that a Stryker Representative would contact their facility to coordinate a service call to inspect the affected units. Questions are directed to the firm via phone at 972-410-7617 or via email at . |
| Quantity | 1498 |
| Distribution | Worldwide --US and Canada, Australia, China (Hong Kong), Latin America (Mexico, Chile, Ecuador, Costa Rica) . |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.