FDA Device recall Z-0389-2024
Achieva 1.5T
- FDA Device
- Class II
- ongoing
- Published 2023-11-29
On 2023-11-29 the FDA classified a Class II recall of Achieva 1.5T 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-0389-2024 |
| 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
Achieva 1.5T
Reason
Potential component failure in the Gradient Coil could product smoke and/or fire.
Identifiers
| code_info | Product No. 781178, 781196, 781296, & 781343; UDI-DI: (01)00884838004108(21)8524, (01)00884838004108(21)32039, (01)0088…Product No. 781178, 781196, 781296, & 781343; UDI-DI: (01)00884838004108(21)8524, (01)00884838004108(21)32039, (01)00884838004108(21)32052, (01)00884838004108(21)32083, (01)00884838004108(21)32087, (01)00884838004108(21)32097, (01)00884838004108(21)32103, (01)00884838004108(21)32118, (01)00884838004108(21)32123, (01)00884838004108(21)32150, (01)00884838004108(21)32153, (01)00884838004108(21)32154, (01)00884838004108(21)32186, (01)00884838004108(21)32223, (01)00884838004108(21)32226, (01)00884838004108(21)32228, (01)00884838004108(21)32230, (01)00884838004108(21)32231, (01)00884838004108(21)32243, (01)00884838004108(21)32247, (01)00884838004108(21)32255, (01)00884838004108(21)32265, (01)00884838004108(21)32288, (01)00884838004108(21)32289, (01)00884838004108(21)32306, (01)00884838004108(21)32350, (01)00884838004108(21)32375, (01)00884838004108(21)32376, (01)00884838004108(21)32385, (01)00884838004108(21)32387, (01)00884838004108(21)32390, (01)00884838004108(21)32392, (01)00884838004108( |
|---|
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-0389-2024%22
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