Aug

2016

Cl II Philips Brilliance 16

Company: Philips Medical Systems, Inc.
Date of Enforcement Report 8/17/2016
Class lI:

PRODUCT

Brilliance 16 Computed Tomography X-ray systems X-ray systems is intended to produce cross-sectional images of the body by computer reconstruction of X-ray transmission data taken at different angles and planes.
Recall Number Z-2369-2016

REASON
Software defect causing intermittently slow response of Host.

RECALLING FIRM/MANUFACTURER
Philips Medical Systems, Inc., Cleveland, OH on 3/24/2016. Voluntary: Firm Initiated recall is ongoing.

VOLUME OF PRODUCT IN COMMERCE
203 units

DISTRIBUTION
Nationwide and Internationally

___________________________________

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 Philips Brilliance 16

Amy Sellers

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