Philips North America Llc: Philips Ingenia Elition S MR System, Model Numbers 781357, 782106, 782137

Hazard

Gradient Coil may act as a heat source with a potential to produce smoke and/or fire.

Details from the source

Reason for recall: Gradient Coil may act as a heat source with a potential to produce smoke and/or fire. Distribution: US Nationwide. Quantity: 566 total Lot/code info: 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.

UPC codes

00884838088108, 00884838098329, 00884838108615

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.