Recall Z-0166-2011
Siemens Medical Solutions USA, Inc · initiated March 31, 2010
Product
Siemens brand 550 TxT Patient Table, Part No. 7346534, Distributed by and/or Manufactured by Siemens AG, Medical Solutions, Germany
Codes / lots: All codes.
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.
FDA-determined cause: Other
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.
Details
- Recall number
- Z-0166-2011
- Initiated
- March 31, 2010
- Posted by FDA
- October 28, 2010
- Terminated
- March 1, 2012
- Product code
- JAI – Couch, Radiation Therapy, Powered
- Quantity
- 326 units
- Distribution
- Worldwide Distribution including USA
- Recalling firm
- Siemens Medical Solutions USA, Inc, Concord, CA