FDA Device recall Z-2209-2025
Ingenia Ambition X Model Numbers (REF): (1) 781356, (2) 782109, (3) 782138
- FDA Device
- Class II
- ongoing
- Published 2025-08-06
On 2025-08-06 the FDA classified a Class II recall of Ingenia Ambition X Model Numbers (REF): (1) 781356, (2) 782109, (3) 782138 by Philips North America, citing the potential for component failures in the Gradient Coil of the affected MR systems may act as a heat source with a potential to produce smoke and/or fire.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2209-2025 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2025-06-30 |
| Published | 2025-08-06 |
| Last updated | 2026-09-13 11:57 UTC |
| Company | Philips North America |
| Distribution | US |
Product
Ingenia Ambition X Model Numbers (REF): (1) 781356, (2) 782109, (3) 782138;
Reason
The potential for component failures in the Gradient Coil of the affected MR systems may act as a heat source with a potential to produce smoke and/or fire.
Identifiers
| code_info | Model Numbers (REF): (1) 781356, (2) 782109, (3) 782138; UDI-DI: (1) 00884838090040, (2) 00884838098350, (3) 0088483810…Model Numbers (REF): (1) 781356, (2) 782109, (3) 782138; UDI-DI: (1) 00884838090040, (2) 00884838098350, (3) 00884838108622; Serial Numbers: (1) 47000, 47001, 47002, 47003, 47004, 47006, 47007, 47009, 47011, 47012, 47013, 47014, 47015, 47016, 47017, 47018, 47019, 47020, 47021, 47022, 47023, 47024, 47025, 47026, 47027, 47028, 47029, 47030, 47032, 47033, 47034, 47035, 47037, 47038, 47039, 47040, 47041, 47043, 47044, 47045, 47047, 47048, 47049, 47050, 47051, 47052, 47053, 47054, 47056, 47057, 47058, 47059, 47060, 47061, 47062, 47063, 47064, 47065, 47066, 47067, 47068, 47070, 47071, 47072, 47074, 47075, 47077, 47078, 47080, 47081, 47082, 47083, 47084, 47085, 47088, 47089, 47090, 47091, 47092, 47093, 47094, 47095, 47096, 47097, 47098, 47099, 47173, 47174, 47175, 47176, 47177, 47183, 47184, 47185, 47187, 47188, 47189, 47190, 47192, 47193, 47194, 47195, 47196, 47197, 47198, 47199, 47200, 47202, 47203, 47204, 47205, 47206, 47207, 47208, 47209, 47210, 47211, 47215, 47216, 47219, 47220, 47221, 4 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:57 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2209-2025%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.