FDA Device recall Z-1714-2016
Philips Healthcare Brilliance iCT Computed Tomography X-Ray System
- FDA Device
- Class II
- terminated
- Published 2016-06-15
On 2016-06-15 the FDA classified a Class II recall of Philips Healthcare Brilliance iCT Computed Tomography X-Ray System by Philips Healthcare, citing 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 le….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1714-2016 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2015-09-06 |
| Published | 2016-06-15 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Philips Healthcare |
| Distribution | AL, AR, AZ, CA, CO, DC, FL, GA, IA, IL, IN, LA, MA, MD, MN, MO, MS, NC, NV, NY, OH, OK, OR, PA, SC, TX, VA, VT, WA |
Product
Philips Healthcare Brilliance iCT Computed Tomography X-Ray System
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
Identifiers
| code_info | Software v. 4.13, 4.14 and 4.15. |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1714-2016%22
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