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U.S. Department of Health and Human Services

Class 2 Device Recall syngo Dynamics

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 Class 2 Recall
syngo Dynamics
see related information
Date Posted March 28, 2007
Recall Status1 Terminated on April 30, 2008
Recall Number Z-0652-2007
Recall Event ID 37347
Premarket Notification
510(K) Number
K053133 
Product Classification System, Image Processing, Radiological - Product Code LLZ
Product Siemens syngo Dynamics 5.0 Workplace. Medical image report and archive system.
Code Information All units. Version 5.0
Recalling Firm/
Manufacturer
Siemens Medical Solutions, USA, Inc
400 Morgan Rd
Ann Arbor, Michigan 48108
For Additional Information Contact S. Nina West
734-205-2423
Manufacturer Reason
for Recall
The cardiac calculation feature may incorrectly calculate a derived V max value (reported out lower than it should be) and certain values imported into worksheets and reports may be incorrect due to a software defect.
FDA Determined
Cause 2
DESIGN: Software Design
Action Distributors were issued a recall letter dated 1/29/07 and asked to notify their customers by issuing their subaccounts a similar letter. When available, new software will be provided.
Quantity in Commerce 71
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 MEDICAL SOLUTIONS USA, INC.
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