28

Nov

2007

Philips Medical Systems AcQPlan software Cl ll

0

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

About the author

Amy Sellers

Amy enjoys researching and writing about developments in medical technology and how that intersects with US law. She received her J.D. from the University of Florida Levin College of Law in 2020 and now works as a Regulatory Associate for SoftwareCPR®, a general-purpose regulatory consulting firm that is recognized globally for their expertise with standards and national regulations pertaining to medical device, mobile medical app, and HealthIT software.

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