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,
FDA device recall Z-0180-2008 · posted 2007-11-21 · Terminated
Recall details
- Recalling firm
- Philips Medical Systems (Cleveland) Inc
- 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
- Action taken
- 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
- Status
- Terminated
- Product code
- JAK
- Quantity affected
- 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,
- Date initiated
- 2007-03-01
- Date posted
- 2007-11-21
- Date terminated
- 2012-03-01
- Location
- Cleveland, OH
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| VOXELSCOPE(TM) (K884268) | Dynamic Digital Displays, Inc. | 1988-12-20 |