Company: Siemens Medical Systems, Inc
Date of Enforcement Report: 1/16/02
Class: III
PRODUCT
Autoperfusion Software used on the ICON workstations designed for use with the E.CAM Emission Imaging Computed Tomography Systems to conduct automated myocardial processing in diagnosing myocardial disease in cardiac SPECT studies. Recall # Z-0427-02.
REASON
The software did not save oblique data correctly
CODE
Autoperfusion Software, versions 1.0 and 1.1installed on ICON P and ICON AP workstations
RECALLING FIRM/MANUFACTURER
Siemens Medical Systems, Inc., Hoffman Estates, IL, by letters dated 11/24/98 and 3/18/99, and software upgrades issued 1/29/99 and 11/5/99. Firm initiated recall is complete.
VOLUME OF PRODUCT IN COMMERCE
211
DISTRIBUTION
Nationwide and Internationally.
