Recall Z-0166-2011 ยท JAI Couch, Radiation Therapy, Powered
Siemens Medical Solutions USA, Inc
Siemens brand 550 TxT Patient Table, Part No. 7346534, Distributed by and/or Manufactured by Siemens AG, Medical Solutions, Germany
| Date | Oct 28, 2010 (initiated Mar 31, 2010) |
| Status | Terminated |
| Reason | 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. |
| Root cause | Other |
| Action | 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. |
| Quantity | 326 units |
| Distribution | Worldwide Distribution including USA |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K050422 | 550 TXT TREATMENT TABLE Siemens Medical Solutions USA, Inc., Mar 18, 2005 |