FDA Device recall Z-2218-2025
Upgrade to MR 7700 Model Number (REF): 782130
- FDA Device
- Class II
- ongoing
- Published 2025-08-06
On 2025-08-06 the FDA classified a Class II recall of Upgrade to MR 7700 Model Number (REF): 782130 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-2218-2025 |
| 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
Upgrade to MR 7700 Model Number (REF): 782130;
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 Number (REF): 782130; UDI-DI: 00884838104402; Serial Numbers: 42030, 42037, 42066, 42151, 42163, 42164, 42211, 42…Model Number (REF): 782130; UDI-DI: 00884838104402; Serial Numbers: 42030, 42037, 42066, 42151, 42163, 42164, 42211, 42219, 42248, 42376, 45001, 45007, 45051, 45052, 45179, 45236, 45297, 45298, 45301, 45552, 45555, 71613, 71907, 85394, 85643, 85644; |
|---|
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-2218-2025%22
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