Cl II Philips Ingenuity Core Model No. 728321;

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


Ingenuity Core Model No. 728321; To produce cross-sectional images of the body.
Recall Number Z-2383-2016

Software issues in software versions v4.1.3/4.1.4/4.1.5 in the Philips Brilliance 64 and Ingenuity CT products that could affect the performance of the equipment.

Philips Medical Systems, Inc., Cleveland, OH on 4/29/2016. Voluntary: Firm Initiated recall is ongoing.

276 Units

Nationwide and Internationally


About the author

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.

What’s New

FDA:  Exemptions, Variances, and Alternate Forms of Adverse Event Reporting for Medical Devices

Manufacturers, importers, and user facilities can request an exemption or variance from any or all of the medical device reporting requirements in 21 CFR Part 803.  Read more:

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