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U.S. Department of Health and Human Services

Class 2 Device Recall syngo Dynamics 9.0

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 Class 2 Recall
syngo Dynamics 9.0
see related information
Date Posted July 08, 2011
Recall Status1 Terminated on July 09, 2012
Recall Number Z-2762-2011
Recall Event ID 58830
Premarket Notification
510(K) Number
Product Classification System, Image Processing, Radiological - Product Code LLZ
Product syngo Dynamics Picture Archiving Communication System The software is a picture archiving and communication system intended for acceptance, transfer, display, storage, archive, and manipulation of digital medical images including quantification and report generation.
Code Information Serial numbers 10091602 and 10091604
Recalling Firm/
Siemens Medical Solutions, USA, Inc
400 Morgan Rd
Ann Arbor, Michigan 48108
For Additional Information Contact Sandy Johanesen
Manufacturer Reason
for Recall
For systems upgraded to syngo Dynamics version 9.0, if a legacy report generated by version 3.x or earlier is opened in the version 9.0 portal, the legacy report may be deleted and replaced with a new report from the version 9.0 reporting system or a blank report.
FDA Determined
Cause 2
DESIGN: Software Design
Action Siemens Medical Solutions, USA, Inc sent a letter entitled "Customer Safety Advisory Notice" to all direct accounts on May 10, 2011. The letter stated the name and version of the software, problem noted, a work-around to be implemented until a service patch is created to fix the problem, and that the letter should be placed in the software's operator's manual to be seen by all who utilize the software.
Quantity in Commerce 38
Distribution Nationwide Distribution
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 MEDICAL SOLUTIONS USA, INC.