Company: Siemens Medical Systems, INC
Date of Enforcement Report: 11/16/01
Class: III
PRODUCT
Autoperfusion Software, which includes The Cardiac Review (Profile Review)
application, 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-0428-02.
REASON
Rest/stress datasets are mislabeled; summed or non-gated data not saved
CODE
Autoperfusion Software, version 1.2 installed on ICON P and ICON AP workstations.
RECALLING FIRM/MANUFACTURER
Siemens Medical Systems, INC. Hoffman Estates, IL, by letter on 2/23/00.Firm initiated recall is ongoing.
VOLUME OF PRODUCT IN COMMERCE
2520 units
DISTRIBUTION
Nationwide
