Jan

2002

Inc ClassIII Siemens Medical Systems

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.

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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Inc ClassIII Siemens Medical Systems

Amy Sellers

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