(1) Ingenia Ambition X (Product Number 781356); (2) Ingenia Ambition… — Class II medical device recall Z-0715-2024
Ongoing recall by Philips North America, reported 2024-01-17, distributed in CA, DE, FL, GA, IL, KY, MA, ME…. The sealed magnet will experience uncontrolled shutdown known as Loss-of-Field (LoF) if the magnet loses cryo-
| Recall number | Z-0715-2024 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Philips North America, Cambridge, MA, United States |
| Recall initiated | 2021-07-15 |
| Classified | 2024-01-11 |
| Reported by FDA | 2024-01-17 |
| Distributed | CA, DE, FL, GA, IL, KY, MA, ME, MI, MO, NH, NJ, NM, NY, OH, PA, PR, SC, TN, TX, VA, VT, WI, WY |
| UPC / GTIN / UDI-DI | 00884838090040, 00884838090057 |
| Serial numbers | 47000, 47001, 47002, 47003, 47004, 47006, 47007, 47009, 47011, 47012, 47013, 47014, 47015, 47016, 47017, 47018, 47019, 47020, 47022, 47023, 47024, 47025, 47026, 47027, 47028 and 200 more |
Product
(1) Ingenia Ambition X (Product Number 781356); (2) Ingenia Ambition S (Product Number 781359)
Reason for recall
The sealed magnet will experience uncontrolled shutdown known as Loss-of-Field (LoF) if the magnet loses cryo-cooling (e.g. caused by a power outage on site.)
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-0715-2024. 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.