Jan

2002

INCClassIII Siemens Medical Systems

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

About the author

Amy Sellers

Amy enjoys researching and writing about developments in medical technology and how that intersects with US law. She received her J.D. from the University of Florida Levin College of Law in 2020 and now works as a Regulatory Associate for SoftwareCPR®, a general-purpose regulatory consulting firm that is recognized globally for their expertise with standards and national regulations pertaining to medical device, mobile medical app, and HealthIT software.

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INCClassIII Siemens Medical Systems

Amy Sellers

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