Company:Philips Medical Systems, Inc.
Date of Enforcement Report 3/14/12
Class ll:
PRODUCT
1) Brilliance Big Bore CT (Computed Tomography) System, 510 (k) #K033357, Model #728243. The recalled CT systems are equipped with Software Version 3.5 Beta 2. Product Usage: The Brilliance Big Bore 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-0777-2012;
2) Brilliance 64 CT (Computed Tomography) System, 510 (k) #K033326, Model #728231, Serial Numbers: 4003, 9875, and 90135. The recalled CT systems are equipped with Software Version 3.5 Beta 2. Product Usage: The Brilliance Big Bore 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-0778-2012;
3) Ingenuity CT (Computed Tomography) System, 510 (k) #K033326, Model #728326. The recalled CT systems are equipped with Software Version 3.5 Beta 2. Product Usage: The Brilliance Big Bore 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-0779-2012
REASON
Software errors. A number of non-conformances were logged during in-house testing and external validation testing of Brilliance 64, Brilliance Big Bore, and Ingenuity CT systems, equipped with software version 3.5 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 letters on October 19, 2011. Firm initiated recall is ongoing.
VOLUME OF PRODUCT IN COMMERCE
9 units
DISTRIBUTION
IN, MI, MO, NY, OH, OR, Germany, Israel and Netherlands
