Company: Philips Medical Systems
Date of Enforcement Report 7/22/2009
Class:ll
PRODUCT
TumorLoc software for the Brilliance Big Bore (BB) and the CT Extended Brilliance Workstation (EBW), Model #4550 116 02431 (TumorLoc). The BB is a CT X-ray system intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data taken at different angles and planes. This device may include signal analysis and display equipment, patient and equipment supports, components and accessories. Recall # Z-1542-2009
REASON
A software error in the TumorLoc software was discovered upon receipt of a customer complaint. There is the potential for data to be lost during reconstruction of images in which slices can either be discarded, or interleaved based upon their series ID.
RECALLING FIRM/MANUFACTURER
Philips Medical Systems (Cleveland) Inc., Cleveland, OH, by letter dated January 28, 2009.
VOLUME OF PRODUCT IN COMMERCE
356 units
DISTRIBUTION
Nationwide and Internationally