Company: Philips Medical Systems t
Date of Enforcement Report:11/28/2007
Class:ll
PRODUCT
Philips, Voxel Q workstations, utilizing AcQSim or AcQPlan software version 4.2, 4.2.1, 4.9, 4.9.1, 4.9.2, 4.9.3, 5.0, 5.0.1, 5.0.2 or 5.0.3 and any Mx8000, Mx8001DT, or Brilliance 6, 10, 16, 16P, and Big Bore CT systems connected to the VoxelQ, Recall # Z-0180-2008
REASON
Incorrect simulation and/or beam placement: An anomaly has been identified with the Philips VoxelQ workstation utilizing AcQPlan software version 4.2, 4.2.1, 4.9, 4.9.1, 4.9.2, 4.9.3, 5.0, 5.0.1, 5.0.2 or 5.0.3 when computing absolute patient marking coordinates with data containing reconstruction offsets from the Mx800, the Mx8001DT, and the Brilliance 6, 10, 16, 16P, and Big Bore CT systems. When data from these systems contain reconstruction offsets, the absolute marking coordinates computed within Virtual Fluoroscopy package can be incorrect. Absolute patient marking coordinates computed on data without any reconstruction offsets are correct.
RECALLING FIRM/MANUFACTURER
Philips Medical Systems (Cleveland) Inc., Cleveland, OH, by letter on November 9, 2007. Firm initiated recall is ongoing.
VOLUME OF PRODUCT IN COMMERCE
520 devices
DISTRIBUTION
Nationwide and Canada
