Philips Healthcare Ingenuity CT Computed Tomography X-Ray System — Class II medical device recall Z-1717-2016
Terminated recall by Philips Healthcare, reported 2016-06-15, distributed in AL, AR, AZ, CA, CO, DC, FL, GA…. Software Defects resulting in: (1) sagittal result shortened for axial scans; (2) single series displayed on c
| Recall number | Z-1717-2016 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Philips Healthcare, Andover, MA, United States |
| Recall initiated | 2015-09-06 |
| Classified | 2016-06-06 |
| Reported by FDA | 2016-06-15 |
| Terminated | 2021-03-04 |
| Distributed | 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 |
| Quantity | 423 |
| Reason classes | software |
Product
Philips Healthcare Ingenuity CT 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
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1717-2016. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.