14
Oct
2015

Siemens SOMATOM Force Cl II

0

Company:Siemens Medical Solutions USA, Inc.
Date of Enforcement Report: 10/14/2015
Class lI:

PRODUCT

SOMATOM Force; computed tomography x-ray system. Intended to generate and process cross-sectional images of patients. Recall Number Z-0107-2016

REASON
Software and firmware bugs

RECALLING FIRM/MANUFACTURER
Siemens Medical Solutions USA, Inc, Malvern, PA on 8/18/2015 Voluntary: Firm Initiated recall is ongoing

VOLUME OF PRODUCT IN COMMERCE
21

DISTRIBUTION
Nationwide

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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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