Philips North America: Evolution Upgrade 3.0T Model Numbers (REF): (1) 782117, (2) 782143;

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: 50 units Lot/code info: Model Numbers (REF): (1) 782117, (2) 782143; UDI-DI: (1) 00884838099739, (2) 00884838108660; Serial Numbers: (1) 42003, 42023, 42024, 42029, 42078, 42217, 42246, 42375, 42402, 42408, 71044, 71348, 71774, 85146, 85645, 85663, 85668, 85675, 85677, 85680, 85685, 85687, 85694, 85698, 85705, 85713, (2) 3, 42069, 42193, 42225, 42308, 42320, 42366, 42415, 71595, 71815, 71836, 85649, 85651, 85682, 85683, 85684, 85688, 85690, 85695, 85697, 85699, 85701, 85708, 85714;

UPC codes

00884838099739, 00884838108660

Source

Official record: FDA (Device enforcement) ↗

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