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U.S. Department of Health and Human Services

Class 2 Device Recall Syngo Imaging Version V31

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 Class 2 Recall
Syngo Imaging Version V31
see related information
Date Posted July 07, 2009
Recall Status1 Open
Recall Number Z-1650-2009
Recall Event ID 52436
Premarket Notification
510(K) Number
K081734 
Product Classification System, Image Processing, Radiological - Product Code LLZ
Product syngo Imaging Version V31 Picture Archiving and Communication System, model number 10014063.
Code Information model number 10014063. Serial numbers: 1141, 1322, 1343, 1353, 1379, 1386, 1387, 1389, 1391, 1392, 1395, 1396, 1402, 1407, 1408, and 1417
Recalling Firm/
Manufacturer
Siemens Medical Solutions USA, Inc
51 Valley Stream Pkwy
Malvern, Pennsylvania 19355
For Additional Information Contact Michael Van Ryn
610-448-4634
Manufacturer Reason
for Recall
Risk of misinterpretation of patient response to treatment: Date displayed may be incorrect. Filtering based on examination date may lead to an incorrect list of examinations.
FDA Determined
Cause 2
DESIGN: Software Design
Action syngo Imaging has issued a Customer Safety Advisory Notice, dated May 28, 2009, to affected customers via Update Instruction IM019/09/S. The notice informs the customers of the potential issue and provides instructions to avoid its occurrence. A software update to correct this issue is currently being developed and will be installed on affected systems by sygo's service representatives when it becomes available.
Quantity in Commerce 16 units
Distribution Nationwide.
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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