Medical Device
Manufacturing
THE TRADE PAPER OF THE FACTORY FLOOR
Z-0166-2011

Siemens brand 550 TxT Patient Table, Part No. 7346534, Distributed by and/or Manufactured by Siemens AG...

Siemens Medical Solutions USA, Inc. / initiated 2010-03-31 / Terminated

Siemens Medical Solutions USA, Inc began a recall of Siemens brand 550 TxT Patient Table, Part No. 7346534, Distributed by and/or Manufactured by Siemens AG, Medical Solutions, Germany on . The reason FDA records is "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...". As of , the recall status on record is Terminated.

Recall record

Recall number
Z-0166-2011
Status
Terminated
Initiated
Posted
Terminated
Recalling firm
Siemens Medical Solutions USA, Inc.
Product
Siemens brand 550 TxT Patient Table, Part No. 7346534, Distributed by and/or Manufactured by Siemens AG, Medical Solutions, Germany
Product code
JAI Couch, Radiation Therapy, Powered
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 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 in commerce
326 units
Distribution
Worldwide Distribution including USA
Product codes and lots
All codes.