Recall Z-0397-2012
Trumpf Medical Systems, Inc. · initiated January 21, 2011
Product
OR table TITAN U, Surgical Table. Surgical bed with Orthopedic Accessories.
Codes / lots: Material number: 1228073, All Serial numbers.
Reason for recall
Product is being recalled due to unintended movement on the Titan Tables.
FDA-determined cause: Device Design
Action taken
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.
Details
- Recall number
- Z-0397-2012
- Initiated
- January 21, 2011
- Posted by FDA
- January 11, 2012
- Terminated
- August 13, 2012
- Product code
- FQO – Table, Operating-Room, Ac-Powered
- Quantity
- see line 1.
- Distribution
- Worldwide Distribution.
- Recalling firm
- Trumpf Medical Systems, Inc., Charleston, SC
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-0394-2012 | OR table TITAN, Surgical Table. Surgical bed with Orthopedic Accessories.Product is being recalled due to unintended movement on the Titan Tables. | 01/21/2011Terminated |
| Z-0395-2012 | OR table TITAN Automatic, Surgical Table. Surgical bed with Orthopedic Accessories.Product is being recalled due to unintended movement on the Titan Tables. | 01/21/2011Terminated |
| Z-0396-2012 | OR table TITAN T, Surgical Table. Surgical bed with Orthopedic Accessories.Product is being recalled due to unintended movement on the Titan Tables. | 01/21/2011Terminated |
| Z-0398-2012 | OR table TITAN UT, Surgical Table. Surgical bed with Orthopedic Accessories.Product is being recalled due to unintended movement on the Titan Tables. | 01/21/2011Terminated |