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U.S. Department of Health and Human Services

Class 2 Device Recall Siemens syngo Imaging XS, all versions

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 Class 2 Recall
Siemens syngo Imaging XS, all versions
see related information
Date Posted January 11, 2012
Recall Status1 Terminated on March 05, 2014
Recall Number Z-0514-2012
Recall Event ID 60425
Premarket Notification
510(K) Number
K082430 
Product Classification System, Image Processing, Radiological - Product Code LLZ
Product syngo Imaging XS, all versions Radiological image processing system
Code Information Model number 10496279
Recalling Firm/
Manufacturer
Siemens Medical Solutions USA, Inc
51 Valley Stream Pkwy
Malvern, Pennsylvania 19355
For Additional Information Contact Anastasia Mason
610-219-4834
Manufacturer Reason
for Recall
Unintended behavior when using syngo Imaging XS, all versions. The "Rename" functionality can cause an unintended patient merge if the renamed patient is sent to another system.
FDA Determined
Cause 2
MISBRANDING: Labeling False and Misleading
Action Siemens Medical Solutions USA, Inc sent a Customer Safety Advisory Notice letter dated August 3, 2011 to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. If you detect patient data inconsistencies in your system caused by this problem, please contact Siemens Service for support. For further questions please call (610) 219-4834.
Quantity in Commerce 38
Distribution Nationwide Distribution including the states of CA, FL, GA, IN, IA, KS, MN, MO, NE, NV, NJ, NY, NC, OH, PA, TN, TX, and WI.
Total Product Life Cycle TPLC Device Report

 
1 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
510(K) Database 510(K)s with Product Code = LLZ and Original Applicant = SIEMENS AG, MEDICAL SOLUTIONS
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