FDA Device recall Z-0392-2024
Ingenia 1.5T CX
- FDA Device
- Class II
- ongoing
- Published 2023-11-29
On 2023-11-29 the FDA classified a Class II recall of Ingenia 1.5T CX by Philips North America, citing potential component failure in the Gradient Coil could product smoke and/or fire.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0392-2024 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2023-10-23 |
| Published | 2023-11-29 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Philips North America |
| Distribution | US |
Product
Ingenia 1.5T CX
Reason
Potential component failure in the Gradient Coil could product smoke and/or fire.
Identifiers
| code_info | Product No. 781261 & 781262; UDI-DI: (01)00884838068438(21)77008, (01)00884838068438(21)77016, (01)00884838068438(21)77…Product No. 781261 & 781262; UDI-DI: (01)00884838068438(21)77008, (01)00884838068438(21)77016, (01)00884838068438(21)77018, (01)00884838068445(21)77032, (01)00884838068445(21)77034, (01)00884838068445(21)77035, (01)00884838068445(21)77038, (01)00884838068445(21)77040, (01)00884838068445(21)77041, (01)00884838068445(21)77046, (01)00884838068445(21)77049, (01)00884838068445(21)77050, (01)00884838068445(21)77054, (01)00884838068445(21)77056, (01)00884838068445(21)77058, (01)00884838068445(21)77059, (01)00884838068445(21)77061, (01)00884838068445(21)77062, (01)00884838068445(21)77065, (01)00884838068445(21)77066, (01)00884838068445(21)77067, (01)00884838068445(21)77071, (01)00884838068445(21)77072, (01)00884838068445(21)77074, (01)00884838068445(21)77075, (01)00884838068445(21)77078, (01)00884838068445(21)77081, (01)00884838068445(21)77083, (01)00884838068445(21)77084, (01)00884838068445(21)77087, (01)00884838068445(21)77093, (01)00884838068445(21)77094, (01)00884838068445(21)77097, (01)00 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0392-2024%22
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