Feb

2018

Philips Brilliance 64 Ct xray system Cl II

Company:Philips Medical Systems (Cleveland) Inc
Date of Enforcement Report 2/14/2018
Class lI:

PRODUCT

Philips Brilliance 64 computed tomography x-ray system
Recall Number Z-0518-2018

REASON
Numerous issues related to software Brilliance iCT 4.1.6 software version.

RECALLING FIRM/MANUFACTURER
Philips Medical Systems (Cleveland) Inc, Cleveland, OH on 10/6/2017. Voluntary: Firm Initiated recall is ongoing.

VOLUME OF PRODUCT IN COMMERCE

DISTRIBUTION
26 US Govt accounts

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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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Philips Brilliance 64 Ct xray system Cl II

Amy Sellers

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