Dec

2016

Siemens SOMATOM Force: Cl II

Company: Siemens Medical Solutions USA, Inc
Date of Enforcement Report 12/14/2016
Class lI:

PRODUCT

SOMATOM Force, System x-ray, tomography, computed
Recall Number Z-0962-2017

REASON
Siemens is providing software update versionVA50A_SP3 to address the software bugs thatwere identified through normal field monitoringand the Global Complaint Handling Process.Correction for the problems are as follows:1. Correction to volumetricmisrepresentations of high contrastobjects when using ADMIRE.2. Correction to highly sporadic scanaborts due to temporarily tubecurrents at 0mA.3.

RECALLING FIRM/MANUFACTURER
Siemens Medical Solutions USA, Inc., Malvern, PA on 10/20/2016 Voluntary: Firm Initiated recall is ongoing.

VOLUME OF PRODUCT IN COMMERCE
48

DISTRIBUTION
Nationwide

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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 SOMATOM Force: Cl II

Amy Sellers

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