Device product
Philips Healthcare Ingenuity Core Computed Tomography X-Ray System
Z-1716-2016
Product summary
- Event
- Event 74149
- Status
- Terminated
- Classification
- Class II
- Quantity
- US-423
- Official record key
device-enforcement:Z-1716-2016
Official wording
Reason: 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
Code information: Software v. 4.13, 4.14 and 4.15.
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.
Derived failure modes
-
Unknown
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