Jun

2016

Ingenuity Computed Tomography X-ray Cl II

Company: Philips Medical Systems, Inc.
Date of Enforcement Report 6/8/2016
Class lI:

PRODUCT

Ingenuity Computed Tomography X-ray Systems, Product Usage: 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-1875-2016

REASON
The firm became aware of a problem where the system may not map Varian drive after CT user logout/login.

RECALLING FIRM/MANUFACTURER
Philips Medical Systems, Inc., Cleveland, OH on 4/8/2016. Voluntary: Firm Initiated recall is ongoing.

VOLUME OF PRODUCT IN COMMERCE
215 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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Ingenuity Computed Tomography X-ray Cl II

Amy Sellers

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