30
May
2018

PET/CT System Cl II Siemens Biograph Horizon

0

Company:Siemens Medical Solutions USA, Inc
Date of Enforcement Report 5/30/2018
Class lI:

PRODUCT
Biograph Horizon, PET/CT System using VJ10A, VJ10B, VJ20A scanners that provide registration and fusion of high resolution physiologic and anatomic information.SOMATOM Force (Model 10742326) Computed tomography x-ray diagnostic system
Recall Number: Z-1930-2018

REASON
Possibility that the Biograph Horizon systems performing CT retrospective cardiac gating or PET cardiac gating examinations may experience a waveform sampling issue caused by a firmware change within the Universal Physiological Measurement Module.

RECALLING FIRM/MANUFACTURER
Siemens Medical Solutions USA, Inc, Hoffman Estates, IL on 2/21/2018. Voluntary: Firm Initiated recall is ongoing.

VOLUME OF PRODUCT IN COMMERCE
14 units

DISTRIBUTION
Nationwide and Internationally

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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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