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
