Company:Philips Medical Systems Ibc.
Date of Enforcement Report 1/11/12
Class ll:

PRODUCT
1) Brilliance Big Bore Computed Tomography X-Ray System, 510(k) #K033357, Model Number: 728243. The recalled device systems are equipped with Version 3.5 Beta 1 software. Recall # Z-0334-2012;

2) Brilliance 64 Computed Tomography X-Ray System, 510(k) #K033326, Model Number: 728231. The recalled device systems are equipped with Version 3.5 Beta 1 software. Recall # Z-0335-2012

REASON
Software errors. A number of non-conformances were found for the Brilliance Big Bore and Brilliance 64 Computed Tomography X-ray Systems equipped with software version; 3.5 Beta1. The non-conformances stem from software errors identified in the operating software.

RECALLING FIRM/MANUFACTURER
Philips Medical Systems (Cleveland) Inc., Cleveland, OH, by a ‘Field Change Order’ (FCO #72800531) on September 12, 2011 and a letter dated October 17, 2011. Firm initiated recall is ongoing.

VOLUME OF PRODUCT IN COMMERCE
five 5) system units

DISTRIBUTION
Nationwide, Italy, India and China