Philips North America: Ingenia 1.5T Model Numbers (REF): (1) 781315, (2) 718641, (3) 781396, (4) 782101, (5) 782115, (6) 782140;

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: 2,279 units Lot/code info: Model Numbers (REF): (1) 781315, (2) 718641, (3) 781396, (4) 782101, (5) 782115, (6) 782140; UDI-DI: (1) 00884838099715, (2) 00884838055322, (3) 00884838009820, (4) 00884838098275, (5) 00884838099043, (6) 00884838108646; Serial Numbers: (1) 61000, 61001, 61002, 61003, 61004, 61005, 61006, 61007, 61008, 61009, 61011, 61013, 61014, 61015, 61016, 61017, 61018, 61019, 61020, 61022, 61023, 61024, 61025, 61026, 61027, 61028, 61029, 61030, 61031, 61032, 61033, 61034, 61035, 61036, 61037, 61038, 61039, 61040, 61041, 61042, 61043, 61044, 61045, 61046, 61047, 61049, 61050, 61051, 61052, 61053, 61054, 61055, 61056, 61057, 61058, 61059, 61060, 61061, 61062, 61063, 61064, 61065, 61066, 61067, 61068, 61069, 61070, 61072, 61073, 61074, 61075, 61076, 61078, 61079, 61080, 61082, 61084, 61085, 61087, 61088, 61091, 61092, 61093, 61094, 61095, 61096, 61097, 61101, 61102, 61103, 61105, 61106, 61107, 61108, 61109, 61112, 61114, 61115, 61116, 61117, 61119, 61123, 61124, 61125, 61126, 61129, 61130, 61131, 61132, 61138, 61140, 61142, 61143, 61144, (2) 70009, 70011, 70013, 70018, 70021, 70022, 70025, 70026, 70027, 70029, 70032, 70037, 70038, 70039, 70040, 70042, 70044, 70046, 70048, 70049, 70050, 70051, 70052, 70053, 70055, 70056, 70057, 70058, 70059, 70062, 70063, 70064, 70065, 70066, 70071, 70072, 70073, 70074, 70075, 70076, 70080, 70084, 70085, 70087, 70088, 70092, 70094, 70095, 70097, 70101, 70104, 70110, 70111, 70113, 70114, 70119, 70122, 70123, 70128, 70129, 70131, 70135, 70136, 70140, 70142, 70

UPC codes

00884838099715, 00884838055322, 00884838009820, 00884838098275, 00884838099043, 00884838108646

Source

Official record: FDA (Device enforcement) ↗

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