FDA Device recall Z-2203-2025
Evolution Upgrade 3.0T Model Numbers (REF): (1) 782117, (2) 782143
- FDA Device
- Class II
- ongoing
- Published 2025-08-06
On 2025-08-06 the FDA classified a Class II recall of Evolution Upgrade 3.0T Model Numbers (REF): (1) 782117, (2) 782143 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-2203-2025 |
| 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
Evolution Upgrade 3.0T Model Numbers (REF): (1) 782117, (2) 782143;
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) 782117, (2) 782143; UDI-DI: (1) 00884838099739, (2) 00884838108660; Serial Numbers: (1) 42003,…Model Numbers (REF): (1) 782117, (2) 782143; UDI-DI: (1) 00884838099739, (2) 00884838108660; Serial Numbers: (1) 42003, 42023, 42024, 42029, 42078, 42217, 42246, 42375, 42402, 42408, 71044, 71348, 71774, 85146, 85645, 85663, 85668, 85675, 85677, 85680, 85685, 85687, 85694, 85698, 85705, 85713, (2) 3, 42069, 42193, 42225, 42308, 42320, 42366, 42415, 71595, 71815, 71836, 85649, 85651, 85682, 85683, 85684, 85688, 85690, 85695, 85697, 85699, 85701, 85708, 85714; |
|---|
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-2203-2025%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.