Cl II Siemens SOMATOM Definition Flash

Company: Siemens Medical Solutions USA, Inc
Date of Enforcement Report 8/31/2016
Class lI:

PRODUCT

SOMATOM Definition Flash with software version VA48A-SP2; Model # 10590000, computed tomography x-ray system.
Recall Number Z-2625-2016

REASON
Due to an internal communication error between the firmware and the software of the components, the planned CT scan executes properly, but the injector is not started. Therefore, the contrast agent is not injected and the desired examination result is not achieved. This error only affects the automatic mode or coupled mode and does not affect the manual control of the injector.

RECALLING FIRM/MANUFACTURER
Siemens Medical Solutions USA, Inc., Malvern, PA on 8/23/2016 Voluntary: Firm Initiated recall is ongoing.

VOLUME OF PRODUCT IN COMMERCE
2 systems

DISTRIBUTION
Distributed to: MI, NY, CA, KY, ND, NE

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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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