FDA Device recall Z-0391-2024
Achieva 1.5T Initial System
- FDA Device
- Class II
- ongoing
- Published 2023-11-29
On 2023-11-29 the FDA classified a Class II recall of Achieva 1.5T Initial System 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-0391-2024 |
| 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 Initial System
Reason
Potential component failure in the Gradient Coil could product smoke and/or fire.
Identifiers
| code_info | Product No. 781178; UDI-DI: N/A; Serial No. 21605, 21695. |
|---|
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-0391-2024%22
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