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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 Device Recall Syngo Imaging Version V31 see related information
Date Initiated by Firm June 01, 2009
Date Posted July 07, 2009
Recall Status1 Terminated 3 on March 19, 2013
Recall Number Z-1650-2009
Recall Event ID 52436
510(K)Number K081734  
Product Classification Picture Archiving and Communication System - 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 PA 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		 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 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) Database 510(K)s with Product Code = LLZ and Original Applicant = SIEMENS AG, MEDICAL SOLUTIONS
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