Siemens brand 550 TxT Patient Treatment Table, part number 7346534; Product is manufactured and distributed by Siemens A
FDA device recall Z-2023-2011 · posted 2011-04-19 · Terminated
Recall details
- Recalling firm
- Siemens Medical Solutions USA, Inc
- Reason for recall
- Potential for causing overheating of the power supply during treatment, and potential for unexpected table descent.
- Action taken
- Siemens issued a Customer Information letter dated March 21, 2010. There were two safety issues. There were two occurrences of smoke caused by an overheating of the power supply during patient treatment. Also, there had been a report of an unexpected lowering of the 550TxT table in patient rescue mode. With the released kit that accompanies this letter, Siemens has implemented a minor modification on the 550TxT to include an additional fuse within the power supply circuit to address the first issue described above. They also included an additional modification to address the lowering of the table by the integration of additional relays. As soon as the "move enable" button is released, the table brake will be enabled which is controlled by the implemented relays. No further action is required for the continued operations of the 550TxT table. Further questions regarding this recall please call (925) 246-8407
- Root cause
- Component design/selection
- Status
- Terminated
- Product code
- JAI
- Quantity affected
- 326 units
- Distribution
- Worldwide Distribution -- Including USA, states of NJ, WI, NY, and MA.
- Date initiated
- 2010-03-31
- Date posted
- 2011-04-19
- Date terminated
- 2012-03-01
- Location
- Concord, CA
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| 550 TXT TREATMENT TABLE (K050422) | Siemens Medical Solutions USA, Inc. | 2005-03-18 |