Philips North America: SmartPath to dStream for 3.0T Model Number (REF): 782145;

Hazard

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.

Details from the source

Reason for recall: 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. Distribution: Worldwide distribution - US Nationwide and the countries of Albania, Algeria, Andorra, Angola, Argentina, Australia, Austria, Bahrain, Bangladesh, Belarus, Belgium, Belize, Bolivia, Bosnia-Herz., Brazil, Bulgaria, Canada, Cayman Islands, Chile, China, Colombia, Costa Rica, C¿te D'Ivoire, Croatia, Cuba, Cyprus, Czech Republic, Denmark, Dominican Rep, Ecuador, Egypt, El Salvador, Estonia, Fiji, Finl Quantity: 15 units Lot/code info: Model Number (REF): 782145; UDI-DI: 00884838108684; Serial Numbers: 17377, 17385, 17435, 34114, 34208, 38118, 38127, 38170, 38294, 38313, 38336, 73002, 73004, 74002, 74004;

UPC codes

00884838108684

Source

Official record: FDA (Device enforcement) ↗

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