23
May
2018

Siemens SOMATOM Definition AS; Cl II

0

Company:Siemens Medical Solutions USA, Inc
Date of Enforcement Report 5/23/2018
Class lI:

PRODUCT

SOMATOM Definition AS (Model 8098027) Computed tomography x-ray diagnostic system
Recall Number: Z-1745-2018

REASON
There is a potential risk of unnecessary radiation exposure due to a software issue found in the CARE Dose4D algorithm implemented in Siemens Healthineers CT scanners of types SOMATOM Definition AS, SOMATOM Definition DS, SOMATOM Definition Edge, SOMATOM Definition Flash and SOMATOM Force..

RECALLING FIRM/MANUFACTURER
Siemens Medical Solutions USA, Inc, Malvern, PA on 11/8/2017. Voluntary: Firm Initiated recall is ongoing.

VOLUME OF PRODUCT IN COMMERCE
1385

DISTRIBUTION
Nationwide, Puerto Rico and Guam

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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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