—#91174

Product

Siemens brand 550 TxT Patient Treatment Table, part number 7346534; Product is manufactured and distributed by Siemens AG, Medical Solutions, Roentgenstrasse 19-21, Kemnath, Germany 95478. The 550 TxT Treatment Table is to be used as an integral part of the Siemens linear accelerator systems to position the patient accurately according to the treatment plan for various radiation therapy treatment techniques.

FDA product code: JAI — Couch, Radiation Therapy, Powered
Device class: Class 2
Medical specialty: Radiology
510(k) numbers: K050422
Affected lot / code info: All units of Listing Number: R864406

Why it was recalled

Potential for causing overheating of the power supply during treatment, and potential for unexpected table descent.

Root cause (FDA determination)

Component design/selection

Action the firm took

Siemens issued a Customer Information letter dated March 21, 2010. There were two safety issues. There were two occurrences of smoke caused by an overheating of the power supply during patient treatment. Also, there had been a report of an unexpected lowering of the 550TxT table in patient rescue mode. With the released kit that accompanies this letter, Siemens has implemented a minor modification on the 550TxT to include an additional fuse within the power supply circuit to address the first issue described above. They also included an additional modification to address the lowering of the table by the integration of additional relays. As soon as the "move enable" button is released, the table brake will be enabled which is controlled by the implemented relays. No further action is required for the continued operations of the 550TxT table. Further questions regarding this recall please call (925) 246-8407

Recalling firm

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

Distribution

Distribution pattern: Worldwide Distribution -- Including USA, states of NJ, WI, NY, and MA.

Timeline

Recall initiated: 2010-03-31
Posted by FDA: 2011-04-19
Terminated: 2012-03-01
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #91174. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.