Sep

2012

Cl lll Brilliance CT 16 System

Company:Philips Medical Systems (Cleveland) Inc.
Date of Enforcement Report 9/26/12
Class lll:

PRODUCT

The Brilliance CT 16 System Product Usage: The Brilliance 16 is a Whole Body Computed Tomography X-ray System intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data from the same axial plane taken at different angles.Recall Number Z-2404-2012

REASON
Philips was notified that the system logout in software version 2.3.6 is now longer and may sometimes fail to logout, requiring a forced system restart or hard shutdown with the power button.

RECALLING FIRM/MANUFACTURER
Philips Medical Systems (Cleveland) Inc., cleveland, OH on 8/28/2012. Voluntary: Firm Initiated recall is ongoing.

VOLUME OF PRODUCT IN COMMERCE
93 units

DISTRIBUTION
Nationwide and Internationally

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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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Cl lll Brilliance CT 16 System

Amy Sellers

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