—#53313

Product

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 product code: JAK — System, X-Ray, Tomography, Computed
Device class: Class 2
Medical specialty: Radiology
510(k) numbers: K884268
Affected lot / code info: Model No. 72870

Why it was recalled

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

Root cause (FDA determination)

Software design

Action the firm took

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.

Recalling firm

Firm: Philips Medical Systems (Cleveland) Inc
Address: 595 Miner Road, Cleveland, Ohio 44143-2131

Distribution

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

Timeline

Recall initiated: 2007-03-01
Posted by FDA: 2007-11-21
Terminated: 2012-03-01
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #53313. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.