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U.S. Department of Health and Human Services

Class 2 Device Recall Siemens brand 550 TxT Patient Table

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 Class 2 Device Recall Siemens brand 550 TxT Patient Tablesee related information
Date Initiated by FirmMarch 31, 2010
Date PostedOctober 28, 2010
Recall Status1 Terminated 3 on March 01, 2012
Recall NumberZ-0166-2011
Recall Event ID 56352
510(K)NumberK050422 
Product Classification Couch, radiation therapy, powered - Product Code JAI
ProductSiemens brand 550 TxT Patient Table, Part No. 7346534, Distributed by and/or Manufactured by Siemens AG, Medical Solutions, Germany
Code Information All codes.
Recalling Firm/
Manufacturer		 Siemens Medical Solutions USA, Inc
4040 Nelson Ave
Concord CA 94520-1200
For Additional Information ContactChristine Dunbar
925-246-8407
Manufacturer 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 2		Other
ActionSiemens 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 Commerce326 units
DistributionWorldwide Distribution including USA
Total Product Life CycleTPLC 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) Database510(K)s with Product Code = JAI
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