Philips North America: MR 7700 Model Numbers (REF): (1) 782120, (2) 782153;

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: 82 units Lot/code info: Model Numbers (REF): (1) 782120, (2) 782153; UDI-DI: (1) 00884838104112, (2) 00884838112858; Serial Numbers: (1) 65000, 65001, 65002, 65003, 65004, 65005, 65006, 65007, 65008, 65009, 65011, 65012, 65013, 65014, 65015, 65016, 65017, 65018, 65019, 65020, 65021, 65023, 65024, 65025, 65026, 65027, 65028, 65029, 65030, 65031, 65032, 65034, 65035, 65037, 65038, 65039, 65040, 65041, 65042, 65043, 65049, 65050, 65051, 65056, 65057, 65059, 65060, 65061, 65063, 65064, 65065, 65066, 65067, (2) 68000, 68001, 68006, 68007, 68008, 68009, 68010, 68011, 68012, 68013, 68014, 68015, 68016, 68017, 68018, 68020, 68022, 68023, 68024, 68025, 68028, 68029, 68030, 68031, 68033, 68034, 68036, 68037, 68041;

UPC codes

00884838104112, 00884838112858

Source

Official record: FDA (Device enforcement) ↗

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