FDA Device recall Z-0461-2023
Philips SmartPath to Ingenia Elition X MR System, Model Numbers 782118, 782132, 782144
- FDA Device
- Class II
- ongoing
- Published 2022-12-14
On 2022-12-14 the FDA classified a Class II recall of Philips SmartPath to Ingenia Elition X MR System, Model Numbers 782118, 782132, 782144 by Philips North America, citing gradient Coil 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-0461-2023 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2022-11-22 |
| Published | 2022-12-14 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Philips North America |
| Distribution | US |
Product
Philips SmartPath to Ingenia Elition X MR System, Model Numbers 782118, 782132, 782144
Reason
Gradient Coil may act as a heat source with a potential to produce smoke and/or fire.
Identifiers
| code_info | Model 782118: Serial Numbers: Included in Letter but No Devices Distributed in the US. Model Number 782132: Serial Num…Model 782118: Serial Numbers: Included in Letter but No Devices Distributed in the US. Model Number 782132: Serial Numbers: Included in Letter but No Devices Distributed in the US. Model Number 782144: Serial Numbers: Included in Letter but No Devices Distributed in the US. |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0461-2023%22
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