Philips Healthcare Ingenuity CT Computed Tomography X-ray system — Class II medical device recall Z-0408-2016
Terminated recall by Philips Electronics North America Corporation, reported 2015-12-23, distributed nationwide. During scans with specific protocol steps, the software unexpectedly sets the Axial ( 2 axis ) scan length to
| Recall number | Z-0408-2016 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Philips Electronics North America Corporation, Andover, MA, United States |
| Recall initiated | 2015-04-14 |
| Classified | 2015-12-12 |
| Reported by FDA | 2015-12-23 |
| Terminated | 2020-09-23 |
| Distributed | Nationwide (US) |
| Countries outside the US | AE, AR, AT, AU, BD, BE, BO, BR, CA, CH, CN, CO, CZ, DE, DK, EE, EG, ES, FI, FR, GB, GR, HK, ID, IE, IL, IN, IR, IT, JO, JP, KE, KR, LB, LT, LV, MX, MY, NL, NO, NZ, PA, PH, PL, PT, SA, SE, SG, TH, TN, TR, TW, VN, ZA |
| Quantity | 105 |
| Reason classes | software |
Product
Philips Healthcare Ingenuity CT Computed Tomography X-ray system
Reason for recall
During scans with specific protocol steps, the software unexpectedly sets the Axial ( 2 axis ) scan length to a different length than the user set in the plan.
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-0408-2016. 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.