FDA Device recall Z-2202-2025
Evolution Upgrade 1.5T Model Numbers (REF): (1) 782116, (2) 782148
- FDA Device
- Class II
- ongoing
- Published 2025-08-06
On 2025-08-06 the FDA classified a Class II recall of Evolution Upgrade 1.5T Model Numbers (REF): (1) 782116, (2) 782148 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-2202-2025 |
| 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 1.5T Model Numbers (REF): (1) 782116, (2) 782148;
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) 782116, (2) 782148; UDI-DI: (1) 00884838099722, (2) 00884838108714; Serial Numbers: (1) 41017,…Model Numbers (REF): (1) 782116, (2) 782148; UDI-DI: (1) 00884838099722, (2) 00884838108714; Serial Numbers: (1) 41017, 41024, 41025, 41041, 41042, 41047, 41051, 41080, 41089, 41130, 41139, 41143, 41144, 41179, 41189, 41196, 41226, 41229, 41235, 41286, 41287, 41295, 41311, 41327, 41344, 41349, 41367, 41413, 41424, 41432, 41433, 41457, 41491, 41497, 41520, 41527, 41568, 70068, 70093, 70099, 70190, 70202, 70205, 70260, 70284, 70589, 70630, 70696, 70949, 70995, 70996, 81021, 81073, 84370, 84741, (2) 41011, 41031, 41182, 41244, 41277, 41284, 41334, 41392, 41427, 41446, 41464, 41488, 41523, 41534, 41547, 70067, 70289, 70452, 70454, 70473, 70590, 70596, 70622, 70644, 70652, 70742, 70769, 70803, 70829, 70966, 70980, 70983, 84102, 84109, 84368, 84435, 84630, 84825, |
|---|
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-2202-2025%22
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