Mar

2012

Cl ll TruFlight Select PET/CT System

Company:Philips Medical Systems, Inc.
Date of Enforcement Report 3/14/12
Class ll:

PRODUCT
TruFlight Select PET/CT System equipped with software version 3.5.3.10, Model #459800111661. A diagnostic imaging system for fixed or mobile installations that combines Positron Emission Tomography (PET) and X-ray Computed Tomography (CT) systems. Recall # Z-1056-2012

REASON
A number of non-conformances have been noted in the TruFlight Select PET/CT System. A number of these non-conformances have been corrected to improve the overall quality and functionality of the suspect system units.

RECALLING FIRM/MANUFACTURER
Philips Medical Systems (Cleveland) Inc., Cleveland, OH, by letter dated December 13, 2011. Firm initiated recall is ongoing..

VOLUME OF PRODUCT IN COMMERCE
2 units

DISTRIBUTION
OH, MD

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 TruFlight Select PET/CT System

Amy Sellers

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