Device product
Philips SmartPath to Ingenia Elition X MR System, Model Numbers 782118, 782132, 782144
Z-0461-2023
Product summary
- Event
- Event 91195
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 566 total
- Official record key
device-enforcement:Z-0461-2023
Official wording
Reason: Gradient Coil may act as a heat source with a potential to produce smoke and/or fire.
Code information: 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.
Distribution pattern: US Nationwide.
Derived failure modes
-
Unknown
Gradient Coil may act as a heat source with a potential to produce smoke and/or fire.