FDA Medical Device Recalls (openFDA)
Philips Medical Systems (Cleveland) Inc: 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
- Recall number
- Z-0180-2008
- Recalling firm
- Philips Medical Systems (Cleveland) Inc
- 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
- Status
- Terminated
- Initiated
- 2007-03-01
- Posted
- 2007-11-21
- Terminated
- 2012-03-01
- Reason
- 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
- Software design
- 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.
- Quantity
- 520 Devices
- Distribution
- 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
- Lot, serial or model codes
- Model No. 72870
- 510(k) numbers
- ["K884268"]
- PMA numbers
- not on file
- Product code
- JAK
- Firm FEI
- 1525965
- Firm city
- Cleveland
- Firm state
- OH
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28