Siemens Medical Solutions USA Class I

Company: Siemens Medical Solutions USA
Date of Enforcemet Report: 8/14/02
Class: I

PRODUCT
e.soft software version 2.0 used on all E.CAM Emission Imaging Computed Tomography Systems with e.soft A or e.soft A/P nuclear medicine workstations. Recall # Z-1189-2.

REASON
Incorrect image time stored for static images resulting in incorrect results.

CODE
e.soft software version 2.0 installed on e.soft A and e.soft A/P workstations.

RECALLING FIRM/MANUFACTURER
Siemens Medical Solutions USA, Inc., Hoffman Estates, IL, by letters and CD on July 12, 2002. Firm initiated recall is ongoing.

VOLUME OF PRODUCT IN COMMERCE
346 units.

DISTRIBUTION
Nationwide and Internationally.

About the author

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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