FDA Device recall Z-2217-2025
SmartPath to Ingenia Elition X Model Numbers (REF): (1) 782118, (2) 782144
- FDA Device
- Class II
- ongoing
- Published 2025-08-06
On 2025-08-06 the FDA classified a Class II recall of SmartPath to Ingenia Elition X Model Numbers (REF): (1) 782118, (2) 782144 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-2217-2025 |
| 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 Ingenia Elition X Model Numbers (REF): (1) 782118, (2) 782144;
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) 782118, (2) 782144; UDI-DI: (1) 00884838099746, (2) 00884838108677; Serial Numbers: (1) 42049,…Model Numbers (REF): (1) 782118, (2) 782144; UDI-DI: (1) 00884838099746, (2) 00884838108677; Serial Numbers: (1) 42049, 42054, 42072, 42085, 42098, 42113, 42158, 42159, 42160, 42167, 42194, 42301, 42306, 42329, 42340, 71019, 71025, 71050, 71528, 85655, 85661, 85665, 85676, (2) 42062, 42105, 42250, 42323, 42346, 42441, 71278, 71366, 71504, 71508; |
|---|
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-2217-2025%22
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