Z-1714-2016 Class II Terminated
Recall Details
- Product Type
- Devices
- Report Date
- June 15, 2016
- Initiation Date
- September 6, 2015
- Termination Date
- March 4, 2021
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- US-423
Product Description
Philips Healthcare Brilliance iCT Computed Tomography X-Ray System
Reason for Recall
Software Defects resulting in: (1) sagittal result shortened for axial scans; (2) single series displayed on console viewer when Creating multi-planner reconstruction; (3) scan length changes with a change in field of view; (4) DoseRight algorithm miscalculations leading to incorrect CTDI values; (5) scan length changes during subsequent axial results, (6) surview scan lengths near 135mm or 184mm
Distribution Pattern
US Distribution - AZ, PA, FL, DC, W VA, NC, SC, AR, OK, OH, NY, NV, TX, PA, IN, CA, MN, MA, DC, MS, MD, OR, IL, CO, MO, VT, IA, AL, LA, GA and WA.
Code Information
Software v. 4.13, 4.14 and 4.15.