Apr

2015

Philips Computed Tomography X-ray Systems Cl II

Company: Philips Medical Systems, Inc.
Date of Enforcement Report 4/8/2015
Class lI:

PRODUCT

Computed Tomography X-ray Systems (Brilliance CT 64-channel w/Essence technology, Brilliance iCT, Brilliance iCT SP, Ingenuity Core, Ingenuity Core128 & Ingenuity CT), Philips Medical Systems, Cleveland, OH Recall Number Z-1359-2015

REASON
Philips discovered that a software defect exists in marketed product wherein the sign indication of the longitudinal position of some types of scan is inverted.

RECALLING FIRM/MANUFACTURER
Philips Medical Systems, Inc., Cleveland, OH 2/5/2015. Voluntary: Firm Initiated recall is ongoing.

VOLUME OF PRODUCT IN COMMERCE
424

DISTRIBUTION
Worldwide

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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 Computed Tomography X-ray Systems Cl II

Amy Sellers

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