Apr

2016

Cl II Siemens SOMATOM

Company: Siemens Medical Solutions USA, Inc.
Date of Enforcement Report 4/27/2016
Class lI:

PRODUCT

Siemens SOMATOM Definition, SOMATOM Definition AS, SOMATOM Definition Flash and SOMATOM Definition Edge; : Intended to produce cross-sectional images of the body.
Recall Number Z-1521-2016

REASON
Siemens initiated a Customer Advisory Notice on 03/07/2016 to inform customers about actions for bug-fixing the following systems: SOMATOM Definition AS, SOMATOM Definition Flash and SOMATOM Definition Edge, which could possibly cause scan aborts, res cans of patients with additional dose, delayed diagnosis and as worst case scenarios, could possibly cause the need of additional contrast medium..

RECALLING FIRM/MANUFACTURER
Siemens Medical Solutions USA, Inc, Malvern, PA on 3/2/2016. Voluntary: Firm Initiated recall is ongoing.

VOLUME OF PRODUCT IN COMMERCE
1096

DISTRIBUTION
Nationwide

___________________________________

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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Cl II Siemens SOMATOM

Amy Sellers

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