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