Company:Philips Medical Systems
Date of Enforcement Report 2/22/12
Class ll:
PRODUCT
) Brilliance 64 Computed Tomography System, Model #728231, 510(k) #K 033326, Serial Numbers: 95504, 91003, 300030, 95130, and 95157. The Brilliance 64 is a Computed Tomography X-Ray System intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data taken at difference angles and planes. This device may include signal analysis and display equipment, patient, and equipment supports, components and accessories. Recall # Z-0360-2012;
2) Ingenuity CT computed Tomography System, Model #728326, 510(k) #KK 033326, Serial Numbers: 300010 and 300018. The Ingenuity CT is a Computed Tomography X-Ray System intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data taken at difference angles and planes. This device may include signal analysis and display equipment, patient, and equipment supports, components and accessories. Recall # Z-0361-2012
REASON
Software errors. A number of non-conformances were logged during in-house testing and external validation testing of Brilliance 64 and Ingenuity CT software version 4.0 Beta 2. The non-conformances are due to software errors identified in these device systems.
RECALLING FIRM/MANUFACTURER
Philips Medical Systems (Cleveland) Inc., Cleveland, OH, by letter dated October 10, 2011. Firm initiated recall is ongoing.
VOLUME OF PRODUCT IN COMMERCE
7 units
DISTRIBUTION
Nationwide, of Australia, China, Belgium, Israel, and Sweden
