Ingenia Ambition X — Class II medical device recall Z-1795-2021
Ongoing recall by Philips North America Llc, reported 2021-06-16, distributed in FL, GA, MI, MO, NH, NJ, NY, PA…. The MR magnet is equipped with 4 lifting blocks, which are positioned on top of the magnet. These blocks are u
| Recall number | Z-1795-2021 |
|---|---|
| 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 | 2021-04-23 |
| Classified | 2021-06-04 |
| Reported by FDA | 2021-06-16 |
| Distributed | FL, GA, MI, MO, NH, NJ, NY, PA, SC, TX, VT |
| Countries outside the US | AE, AT, AU, BD, BE, BR, CH, DE, DK, ES, FI, FR, GB, IQ, IT, JP, NL, OM, TH |
| Quantity | 156 mr |
| UPC / GTIN / UDI-DI | 00884838090040, 00884838098350 |
| Serial numbers | 47000, 47001, 47002, 47003, 47009, 47012, 47013, 47014, 47015, 47016, 47017, 47019, 47023, 47024, 47025, 47028, 47030, 47033, 47034, 47035, 47040, 47045, 47047, 47049, 47050 and 48 more |
| Model numbers | 781356, 782109 |
Product
Ingenia Ambition X - Model Number: 781356, Diagnostic MR system. ***Updated November 2023*** Added Model Number 782109 - Ingenia Ambition X
Reason for recall
The MR magnet is equipped with 4 lifting blocks, which are positioned on top of the magnet. These blocks are used to allow the magnets to be moved in or out by a lifting crane, e.g. during decommissioning or moving activities. A mechanical issue was detected on these hoisting interface blocks on top of the magnet.
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-1795-2021. 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.