Company: Siemens Medical Solutions USA, Inc.,
Date of Enforcement Report 5/7/2008
Class:ll
PRODUCT
Leonardo Workstation Picture Archiving and Communication System, Model Number: 7129534, Software Version: VB30B, Recall # Z-1038-2008
REASON
Incorrect display: The orientation labels will be incorrectly displayed on the reconstructed InSpace 3-D image if the orientation was not originally HFS on the acquisition system.
RECALLING FIRM/MANUFACTURER
Recalling Firm: Siemens Medical Solutions USA, Inc., Malvern, PA, by letter dated December 21, 2007
Manufacturer: Siemens AG, Medical Solution, Forchheim, Germany. Firm initiated recall is ongoing.
VOLUME OF PRODUCT IN COMMERCE
47 units
DISTRIBUTION
Nationwide
