Philips, Voxel Q workstations, untilizing 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, Philips Medical Systems, Cleveland, OH 44143
FDA Recall Z-0180-2008 · Posted 2007-11-21
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Recalling FirmPhilips Medical Systems (Cleveland) Inc
Recall StatusTerminated
Product CodeJAK
Date Initiated2007-03-01
Date Terminated2012-03-01
Product Quantity520 Devices
Reason for Recall
Incorrect simulation and/or beam placement: An anomaly has been identified with the Philips VoxelQ workstation utlizing 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. Whe
Firm Action
On November 1, 2007, after telcon with FDA, the firm revised its recall strategy to notify consignees via a November 9, 2007, Urgent Device Notification letter which indicates that warning labels will be affixed to the units that alerts the user of the reconstruction offset defect by Philips employees.
Root Cause
Software design
Distribution Pattern
Worldwide Distribution- USA including states of AL, AR, AZ, CA, CO, CT, DC, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, TN, TX, UT, VA, WA, WI, WV and WY and Canada
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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