Class II Siemens syngo Dynamics 5.0 Workplace

Company:Siemens Medical Solutions
Date of Enforcement Report:4/6/2007
Class:ll

PRODUCT
Siemens syngo Dynamics 5.0 Workplace. Medical image report and archive system, Recall # Z-0652-2007

REASON
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.

CODE
All units. Version 5.0

RECALLING FIRM/MANUFACTURER
Siemens Medical Solutions, USA, Inc., Ann Arbor, MI., by letter dated January 29, 2007. Firm initiated recall is ongoing.

VOLUME OF PRODUCT IN COMMERCE
62 units

DISTRIBUTION
Nationwide

About the author

Amy Sellers

Amy enjoys researching and writing about developments in medical technology and how that intersects with US law. She received her J.D. from the University of Florida Levin College of Law in 2020 and now works as a Regulatory Associate for SoftwareCPR®, a general-purpose regulatory consulting firm that is recognized globally for their expertise with standards and national regulations pertaining to medical device, mobile medical app, and HealthIT software.

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Class II Siemens syngo Dynamics 5.0 Workplace

Amy Sellers

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