Ingenuity CT (Computed Tomography) System, 510 (k) #K033326, Model #728326, Serial Numbers: 300003, 300004, and 300005. 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.

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.

Philips sent an "URGENT - Medical Device Correction" notification letters to all affected customers via Certified mail on October 19, 2011. The letter describes the referenced software issues; provides instructions to the customers as to what they can do in order to address these issues; and informs the customers of the firm's upcoming software field/correction. The letter states that a Philips representative will be contacting all affected customers to install the necessary software upgrade through a Field Change Order. This will be implemented free of charge. For information or support contact your local Philips representative or local Philips Healthcare office. For North America and Canada contact the Customer Care Solution Center 1-800-722-9377, option 5.