Company: Siemens Medical Solutions USA
Date of Enforcemet Report: 8/14/02
e.soft software version 2.0 used on all E.CAM Emission Imaging Computed Tomography Systems with e.soft A or e.soft A/P nuclear medicine workstations. Recall # Z-1189-2.
Incorrect image time stored for static images resulting in incorrect results.
e.soft software version 2.0 installed on e.soft A and e.soft A/P workstations.
Siemens Medical Solutions USA, Inc., Hoffman Estates, IL, by letters and CD on July 12, 2002. Firm initiated recall is ongoing.
VOLUME OF PRODUCT IN COMMERCE
Nationwide and Internationally.