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U.S. Department of Health and Human Services

Class 2 Device Recall Syngo Imaging

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 Class 2 Recall
Syngo Imaging
see related information
Date Posted June 24, 2010
Recall Status1 Terminated on July 05, 2012
Recall Number Z-1892-2010
Recall Event ID 55651
Premarket Notification
510(K) Number
K082430 
Product Classification System, Image Processing, Radiological - Product Code LLZ
Product Syngo Imaging Version Lines VB20, VB30, VB35 in combination with a RIS.
Code Information Material number 10014063. Serial numbers 1043, 1114, and 1198. Version Lines VB20, VB30, & VB35.
Recalling Firm/
Manufacturer
Siemens Medical Solutions USA, Inc
51 Valley Stream Pkwy
Malvern, Pennsylvania 19355
Consumer Instructions No consumer action necessary
For Additional Information Contact Customer Service
610-219-6300
Manufacturer Reason
for Recall
Siemens has become aware of a potential malfunction and hazard to patients when using Syngo Imaging version lines VB20, VB30, VB35A in combination with a RIS that is violating DICOM Standard by creating non-unique study instance UIDs.
FDA Determined
Cause 2
DESIGN: Device Design
Action The recalling firm sent a Customer Safety Advisory Notice, dated 04-06-2010, to customers explaining when the malfunction occurs and the potential risks, steps to avoid potential risk of the issue by ensuring that the RIS works according to DICOM Standard and does not create double study instance UIDs. Siemens Service Reps will contact the consignees in a timely manner to check if there are symptoms for the reported issues. The issue will be resolved with a Software-Update for each affected version, except for version VB20. All customers on VB20 will be upgraded.
Quantity in Commerce 3 units
Distribution Nationwide Distribution -- Including CT, NM, & 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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