—#93284

Product

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

FDA product code: JAI — Couch, Radiation Therapy, Powered
Device class: Class 2
Medical specialty: Radiology
510(k) numbers: K050422
Affected lot / code info: All codes.

Why it was recalled

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 (FDA determination)

Other

Action the firm took

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.

Recalling firm

Firm: Siemens Medical Solutions USA, Inc
Address: 4040 Nelson Ave, Concord, California 94520-1200

Distribution

Distribution pattern: Worldwide Distribution including USA

Timeline

Recall initiated: 2010-03-31
Posted by FDA: 2010-10-28
Terminated: 2012-03-01
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #93284. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.