FDA Device recall Z-2215-2025
SmartPath to dStream for 3.0T Model Number (REF): 782145
- FDA Device
- Class II
- ongoing
- Published 2025-08-06
On 2025-08-06 the FDA classified a Class II recall of SmartPath to dStream for 3.0T Model Number (REF): 782145 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-2215-2025 |
| 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
SmartPath to dStream for 3.0T Model Number (REF): 782145;
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): 782145; UDI-DI: 00884838108684; Serial Numbers: 17377, 17385, 17435, 34114, 34208, 38118, 38127, 38…Model Number (REF): 782145; UDI-DI: 00884838108684; Serial Numbers: 17377, 17385, 17435, 34114, 34208, 38118, 38127, 38170, 38294, 38313, 38336, 73002, 73004, 74002, 74004; |
|---|
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-2215-2025%22
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