Recall Z-0395-2012 ยท FQO Table, Operating-Room, Ac-Powered
Trumpf Medical Systems, Inc.
OR table TITAN Automatic, Surgical Table. Surgical bed with Orthopedic Accessories.
| Date | Jan 11, 2012 (initiated Jan 21, 2011) |
| Status | Terminated |
| Reason | Product is being recalled due to unintended movement on the Titan Tables. |
| Root cause | Device Design |
| Action | Trumpf Medical Systems sent an initial notification to customers dated January 24, 2011. A subsequent "URGENT SAFETY NOTICE-UPDATE" letter dated May 26, 2011 was sent to all affected customers. The letter described the product, problem, and actions to be taken by the customers. A Corrective Action Plan includes a software update to be installed by a Trumpf Technical Service Representative. Contact Technical Service at 888-474-9359 for questions regarding this notice. |
| Quantity | see line 1. |
| Distribution | Worldwide Distribution. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.