Philips North America: SmartPath to Ingenia Elition X Model Numbers (REF): (1) 782118, (2) 782144;

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: 33 units Lot/code info: Model Numbers (REF): (1) 782118, (2) 782144; UDI-DI: (1) 00884838099746, (2) 00884838108677; Serial Numbers: (1) 42049, 42054, 42072, 42085, 42098, 42113, 42158, 42159, 42160, 42167, 42194, 42301, 42306, 42329, 42340, 71019, 71025, 71050, 71528, 85655, 85661, 85665, 85676, (2) 42062, 42105, 42250, 42323, 42346, 42441, 71278, 71366, 71504, 71508;

UPC codes

00884838099746, 00884838108677

Source

Official record: FDA (Device enforcement) ↗

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