Philips North America: MR 5300 Model Numbers (REF): (1) 782110, (2) 782135 (China ONLY), (3) 782152;

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: 551 units Lot/code info: Model Numbers (REF): (1) 782110, (2) 782135, (3) 782152; UDI-DI: (1) 00884838099364, (2) None, (3) 00884838112841; Serial Numbers: (1) 63000, 63001, 63006, 63007, 63008, 63009, 63010, 63011, 63012, 63013, 63014, 63015, 63016, 63018, 63019, 63021, 63022, 63023, 63024, 63025, 63026, 63027, 63028, 63029, 63030, 63031, 63032, 63033, 63034, 63035, 63036, 63038, 63039, 63041, 63042, 63043, 63044, 63046, 63047, 63049, 63050, 63051, 63053, 63054, 63057, 63058, 63059, 63060, 63062, 63063, 63064, 63066, 63067, 63068, 63069, 63070, 63071, 63072, 63074, 63075, 63076, 63078, 63079, 63080, 63082, 63083, 63084, 63085, 63086, 63087, 63090, 63091, 63092, 63093, 63094, 63095, 63096, 63097, 63098, 63099, 63100, 63103, 63104, 63105, 63106, 63107, 63108, 63109, 63110, 63111, 63112, 63113, 63115, 63116, 63119, 63121, 63122, 63123, 63125, 63126, 63127, 63128, 63130, 63132, 63134, 63135, 63136, 63137, 63138, 63139, 63140, 63141, 63142, 63143, 63144, 63146, 63148, 63149, 63150, 63151, 63152, 63153, 63154, 63155, 63156, 63157, 63159, 63160, 63161, 63162, 63164, 63165, 63166, 63168, 63169, 63172, 63174, 63175, 63176, 63177, 63178, 63182, 63183, 63186, 63187, 63188, 63190, 63191, 63193, 63194, 63195, 63196, 63197, 63198, 63199, 63200, 63201, 63202, 63203, 63210, 63211, 63218, 63219, 63220, 63221, 63222, 63223, 63224, 63226, 63227, 63228, 63229, 63235, 63236, 63237, 63238, 63239, 63240, 63243, 63244, 63247, 63248, 63250, 63252, 63253, 63257, 63258, 63259, 63260, 63261, 63262, 63263, 63264, 63265, 63266,

UPC codes

00884838099364, 00884838112841

Source

Official record: FDA (Device enforcement) ↗

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