Company: Philips Medical Systems
Date of Enforcement Report 7/8/2009
Class:ll
PRODUCT
Brilliance iCT software v2.5.0, Model 728306. The Brilliance iCT is packaged INA carton and the software is contained within the Brilliance CT scanner. The ‘Brilliance iCT’ is a Computed Tomography X-ray System intended to produce cross-section images of the body by computer reconstruction of x-ray transmission data taken at different Ganges and planes. This device may include signal analysis and display equipment, patient, and equipment supports, components and accessories. Recall # Z-1582-2009
REASON
Software anomaly. An artifact may appear in brain scans and brain perfusion studies, when using 80kV and a UA, UB, or UC filter with this CT scanning device.
RECALLING FIRM/MANUFACTURER
Philips Medical Systems (Cleveland) Inc, Cleveland, OH, by letters dated December 22, 2008 and January 29, 2009. Firm initiated recall is ongoing.
VOLUME OF PRODUCT IN COMMERCE
44 units
DISTRIBUTION
DC, CA, GA, IL, IN, KY, NY, MD, MN, OH, OR, MD, Germany, Greece, Israel, Italy, Japan, Netherlands, Norway, Russia, South Korea, Switzerland, Taiwan, Canada, and Thailand
