Ingenia Ambition S — Class II medical device recall Z-3197-2024
Ongoing recall by Philips North America Llc, reported 2024-10-02, distributed nationwide. Integrated Radio Frequency (IRF) Carrier assembly screws may come loose and protrude beyond the surface could
| Recall number | Z-3197-2024 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Philips North America Llc, Cambridge, MA, United States |
| Recall initiated | 2024-09-03 |
| Classified | 2024-09-20 |
| Reported by FDA | 2024-10-02 |
| Distributed | Nationwide (US) |
| Countries outside the US | AR, AU, BE, BR, CA, CH, CL, CN, CO, CZ, DE, DK, EC, EG, ES, FI, FR, GB, HR, ID, IL, IN, IQ, IR, IS, IT, JO, JP, KR, KW, LV, MA, MX, NL, PE, PK, PL, PT, QA, RO, SA, SG, SI, TH, VN, ZA |
| Quantity | 64 units |
| UPC / GTIN / UDI-DI | 00884838090057, 00884838098343 |
| Serial numbers | 27506, 27508, 27509, 27512, 27514, 27515, 27516, 27517, 27518, 27519, 27520, 27523, 27524, 27525, 27526, 27528, 27531, 48146, 48164, 48550, 48556, 48588, 48589, 48608, 48612 and 39 more |
| Model numbers | 781359, 782108, 782133 |
Product
Ingenia Ambition S - For use as a diagnostic device to obtain cross-sectional images, spectroscopic images and/or spectra of the internal structure of the head, body or extremities, in any orientation. (REF) Numbers: 1) 782108 2) 781359 3) 782133
Reason for recall
Integrated Radio Frequency (IRF) Carrier assembly screws may come loose and protrude beyond the surface could cause the screws to interfere with other moving parts, potentially blocking the horizontal tabletop. May lead to delay in diagnosis and/or may include anxiety of a patient is left on the tabletop inside the bore for a longer duration than anticipated. movement.
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-3197-2024. 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.