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U.S. Department of Health and Human Services

Class 2 Device Recall Siemens brand 550 TxT Patient Treatment Table

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  Class 2 Device Recall Siemens brand 550 TxT Patient Treatment Table see related information
Date Initiated by Firm March 31, 2010
Date Posted April 19, 2011
Recall Status1 Terminated 3 on March 01, 2012
Recall Number Z-2023-2011
Recall Event ID 55577
510(K)Number K050422  
Product Classification Couch, radiation therapy, powered - Product Code JAI
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.
Code Information All units of Listing Number: R864406
Recalling Firm/
Manufacturer		 Siemens Medical Solutions USA, Inc
4040 Nelson Ave
Concord CA 94520-1200
For Additional Information Contact Christine Dunbar
925-246-8407
Manufacturer Reason
for Recall		 Potential for causing overheating of the power supply during treatment, and potential for unexpected table descent.
FDA Determined
Cause 2		 Component design/selection
Action 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
Quantity in Commerce 326 units
Distribution Worldwide Distribution -- Including USA, states of NJ, WI, NY, and MA.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = JAI and Original Applicant = SIEMENS MEDICAL SOLUTIONS USA, INC.
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