Mar

2013

Cl ll Philips Ingenuity TF PET/CT Diagnostic imag

Company:Philips Medical Systems Inc.
Date of Enforcement Report 3/6/2013
Class ll:

PRODUCT

Ingenuity TF PET/CT Diagnostic imaging system Recall Number Z-0897-2013

REASON
Issues have been detected in the Ingenuity TF PET/CT currently running Ingenuity TF PET/CT system software version 4.0.0.26635 that if they were to re-occur, could cause a risk for patients.

RECALLING FIRM/MANUFACTURER
Philips Medical Systems Inc., Cleveland, OH on 1/21/2013. Voluntary: Firm Initiated recall is ongoing.

VOLUME OF PRODUCT IN COMMERCE
1 unit

DISTRIBUTION
Ohio

___________________________________

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 ll Philips Ingenuity TF PET/CT Diagnostic imag

Amy Sellers

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