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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 April 28, 2009
Recall Status1 Terminated on September 23, 2009
Recall Number Z-1266-2009
Recall Event ID 51563
Premarket Notification
510(K) Number
K071114 
Product Classification System, Image Processing, Radiological - Product Code LLZ
Product syngo Imaging model number 10014063. Affected systems are V30A or earlier with an NFS connected archive and V30A systems where image data was stored to LTS using software version older than V30A. Picture Archiving and communications system
Code Information Serial numbers: 1279, 1210, 1246, 1198, 1105, 1227, 1064, 1058, 1083, 1090, 1189, 1061, 1258, 1119, 1039, 1040, 1074, 1079, 1282 and 1056.
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
An issue concerning archived image data that is sporadically saved with corrupted data may occur. This issue may occur when syngo Imaging is configured to archive image data on a network file system (NFS) connected via a connected archive (Mount Point Solution).
FDA Determined
Cause 2
DESIGN: Software Design
Action A Customer Safety Advisory Notice, dated 02/09/2009 was sent to affected customers via Update Instruction IM013/09S. The letter informs customers of when the malfunction occurs and the potential issue, provides instructions to avoid its occurrence, and how the issue will be resolved. Customers are to ensure that the Safety Advisory is placed in the system's instructions for use and contact their SIEMENS Uptime Service Senter if they have any questions.
Quantity in Commerce 20 units
Distribution Nationwide Distribution -- including states of AL, CA, CT, FL, LA, MI, MO, NC, NJ, OH, PA, TN, 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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