Company:Philips Medical Systems (Cleveland) Inc
Date of Enforcement Report 2/22/12
Class ll:
PRODUCT
Computed Tomography X-Ray Systems (Brilliance 64, Model Number: 728231; Brilliance Big Bore, Model Number: 728243; Brilliance iCT, Model Number: 728306; Brilliance iCT SP, Model Number: 728311; and Ingenuity CT, Model Number: 728326). Intended to produce cross-sectional images of the body by comcomputer reconstruction of x-ray transmission data taken at different angles and planes. Recall # Z-0845-2012
REASON
The Common Image Reconstruction System (CIRS) on the affected Brilliance Systems encounters an error and requires reboot of the system. The unit failed to initialize axial scan due to timeout that occurred waiting for “READY” state.
RECALLING FIRM/MANUFACTURER
Philips Medical Systems (Cleveland) Inc., Cleveland, OH, by letter on October 10, 2011. Firm initiated recall is ongoing.
VOLUME OF PRODUCT IN COMMERCE
548 units
DISTRIBUTION
Nationwide and Internationally