Philips North America: Upgrade to MR 7700 Model Number (REF): 782130;

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: 26 units Lot/code info: Model Number (REF): 782130; UDI-DI: 00884838104402; Serial Numbers: 42030, 42037, 42066, 42151, 42163, 42164, 42211, 42219, 42248, 42376, 45001, 45007, 45051, 45052, 45179, 45236, 45297, 45298, 45301, 45552, 45555, 71613, 71907, 85394, 85643, 85644;

UPC codes

00884838104402

Source

Official record: FDA (Device enforcement) ↗

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