Device product
Philips Ingenia Elition S MR System, Model Numbers 781357, 782106, 782137
Z-0459-2023
Product summary
- Event
- Event 91195
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 566 total
- Official record key
device-enforcement:Z-0459-2023
Official wording
Reason: Gradient Coil may act as a heat source with a potential to produce smoke and/or fire.
Code information: Model 781357: UDI-DI: 00884838088108; Serial Numbers: 46002 46014 46025 46065 46077 46088 46097 46109 46071; Model 782106: UDI-DI: 00884838098329; Serial Numbers: 46224 46225 46265 46269 46311; Model Number 782137: UDI-DI: 00884838108615; 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.