Company:Philips Medical Systems
Date of Enforcement Report 4/11/12
Brilliance 64 and Ingenuity CT Computed Tomography X-Ray Systems. Brilliance 64 Model # 728231, Ingenuity CT Model # 728326. The Brilliance 64 and Ingenuity CT are Computed Tomography X-Ray Systems intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data taken at different angles and planes. These devices may include signal analysis and display equipment, patient, and equipment supports, components and accessories. Recall # Z-1361-2012
Philips Healthcare is performing an upgrade to the field for issues related to Philips Brilliance 64 and Ingenuity CT scanner having Software Version 3.5.1. When the user plans a scan with tilt applied, the scan increment changes from the user defined values (noncontiguous) to a contiguous scan..
Philips Medical Systems (Cleveland) Inc., Cleveland, OH, by letter dated March 14, 2012. Firm initiated recall is ongoing.
VOLUME OF PRODUCT IN COMMERCE
Nationwide and Internationally