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U.S. Department of Health and Human Services

Class 2 Device Recall Syngo Imaging XS

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 Class 2 Recall
Syngo Imaging XS
see related information
Date Posted November 10, 2009
Recall Status1 Terminated on July 05, 2012
Recall Number Z-0174-2010
Recall Event ID 53564
Premarket Notification
510(K) Number
K082430 
Product Classification System, Image Processing, Radiological - Product Code LLZ
Product Syngo Imaging XS VA60 and VA70 in combination with a NAS or HSM license
Code Information Model number 7502029 - serial number 14086 and Model number 10496279 - serial number 1418
Recalling Firm/
Manufacturer
Siemens Medical Solutions USA, Inc
51 Valley Stream Pkwy
Malvern, Pennsylvania 19355
For Additional Information Contact Customer Service
610-219-6300
Manufacturer Reason
for Recall
Incomplete amount of image data; specifically, The image count in the series table of the online and archive database will display the full amount of images received at the Syngo Imaging XS as archived. However, the zip file on the NAS or HSM will contain fewer images-those which have been archived until the time of the error/interruption.
FDA Determined
Cause 2
DESIGN: Software Design
Action The recalling firm issued a "Customer Safety Advisory Notice" dated 9/14/09 to all affected customers via Update Instructions IM101/09/S. The notice informs the customer of the potential issue and provides instructions to avoid its occurrence. Questions regarding this issue are directed to the local SIEMENS Uptime Service Center.
Quantity in Commerce 2 units
Distribution The product was shipped to medical facilities in NY and OH
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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