Siemens brand 550 TxT Patient Table, Part No. 7346534, Distributed by and/or Manufactured by Siemens AG, Medical Solutio
FDA device recall Z-0166-2011 · posted 2010-10-28 · Terminated
Recall details
- Recalling firm
- Siemens Medical Solutions USA, Inc
- Reason for recall
- An increase in voltage may cause a short circuit of a power transistor that may cause a smoldering and smoking effect of the electrical wiring and also an unexpected lowering of the Table. Both issues present the potential for injury to a patient or the operator.
- Action taken
- Siemens sent a Customer Information Letter on March 31, 2010, to all consignees. The letter identified the product, the problem, and the action that should be taken. Siemens implemented minor modifications to address the issues. No further action was required for the continual operation of the 550TxT Table. For questions regarding this recall call 925-602-8083.
- Root cause
- Other
- Status
- Terminated
- Product code
- JAI
- Quantity affected
- 326 units
- Distribution
- Worldwide Distribution including USA
- Date initiated
- 2010-03-31
- Date posted
- 2010-10-28
- 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 |