Company: Siemens Medical Solutions USA
Date of Enforcemet Report: 8/14/02
Class: I
PRODUCT
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.
REASON
Incorrect image time stored for static images resulting in incorrect results.
CODE
e.soft software version 2.0 installed on e.soft A and e.soft A/P workstations.
RECALLING FIRM/MANUFACTURER
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
346 units.
DISTRIBUTION
Nationwide and Internationally.
