Apr

2003

Siemens Medical Solutions Class III

Company: Siemens Medical Solutions
Date of Enforcement Report: 4/30/03
Class: III

PRODUCT
ICON 9.5 Software used on the ICON workstations designed for use with the E.CAM Emission Imaging Computed Tomography Systems. Recall # Z-0727-03.

REASON
ICON 9.5 software does not apply flood corrections during whole body SPECT studies with multiple bed positions.

CODE
All Diacam, Multispect 2, Multispect 3 and e.cam camera systems with ICON workstations with ICON software version 9.5 and the optional Whole Body SPECT software.

RECALLING FIRM/MANUFACTURER
Siemens Medical Solutions, USA, Inc., Hoffman Estates, IL, by letters dated February 10, 2003. Firm initiated recall is ongoing.

VOLUME OF PRODUCT IN COMMERCE
600 units.

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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Siemens Medical Solutions Class III

Amy Sellers

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