Philips Medical Systems CT X-Ray Cl II

Company: Philips Medical Systems (Cleveland) Inc
Date of Enforcement Report:11/14/2007
Class:ll

PRODUCT
The Brilliance CT Big Bore is a whole body computed tomography X-Ray system. The malfunctioning software application is the Tumor Localization (Tumor LOC) application.
All Brilliance CT Big Bore Scanners with Tumor Localization software versions v2.2.1, v2.2.2, & v2.2.5. This software version is included on Brilliance CT Big Bore Scanners, Model Number 728243; Recall # Z-0121-2008

REASON
The maximum intensity projection (MIP) images produced from respiratory gated images by the Tumor Localization (Tumor LOC) software application on Brilliance Big Bore CT scanners will be labeled incorrectly for certain patient orientations and view conventions when saved for later viewing.

RECALLING FIRM/MANUFACTURER
Philips Medical Systems (Cleveland) Inc., Cleveland, OH, by letters on October 1, 2007. Firm initiated recall is ongoing.

VOLUME OF PRODUCT IN COMMERCE
206 units

DISTRIBUTION
Nationwide and Internationally

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