Oct

2014

Cl II Philips Ingenuity CT scanners

Company: Philips Medical Systems (Cleveland) Inc
Date of Enforcement Report: 10/7/2014
Class lI:

PRODUCT

The Ingenuity CT, Ingenuity Core, and Ingenuity Core128 scanners are Computed Tomography X-ray systems intended to produce cross-sectional images of the body by computer reconstruction of X-ray transmission data taken at different angles and planes. This device may include signal analysis and display equipment, patient and equipment supports, components and accessories
Recall Number Z-2711-2014

REASON
Ingenuity CT system can mislabel the exposure that results in an image in the incorrect order that it was taken by the user.

RECALLING FIRM/MANUFACTURER
Philips Medical Systems (Cleveland) Inc, cleveland, OH on 9/11/2014 Voluntary: Firm Initiated recall is ongoing

VOLUME OF PRODUCT IN COMMERCE
79

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 II Philips Ingenuity CT scanners

Amy Sellers

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