Philips North America: Ingenia 3.0T CX Model Numbers (REF): (1) 781271, (2) 782105;

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: 350 units Lot/code info: Model Numbers (REF): (1) 781271, (2) 782105; UDI-DI: (1) 00884838068452, (2) 00884838098312; Serial Numbers: (1) 78000, 78003, 78004, 78005, 78007, 78008, 78009, 78010, 78011, 78012, 78013, 78014, 78015, 78016, 78017, 78018, 78019, 78021, 78022, 78023, 78025, 78026, 78027, 78028, 78029, 78030, 78031, 78032, 78033, 78034, 78035, 78036, 78038, 78039, 78040, 78042, 78043, 78044, 78045, 78046, 78047, 78048, 78049, 78050, 78051, 78053, 78058, 78059, 78060, 78062, 78063, 78064, 78065, 78066, 78067, 78068, 78070, 78071, 78072, 78073, 78074, 78075, 78076, 78077, 78081, 78082, 78083, 78084, 78086, 78087, 78088, 78089, 78091, 78092, 78095, 78096, 78097, 78098, 78099, 78100, 78101, 78102, 78103, 78104, 78106, 78107, 78109, 78110, 78111, 78112, 78113, 78114, 78115, 78117, 78118, 78120, 78121, 78122, 78123, 78126, 78127, 78128, 78129, 78132, 78133, 78135, 78137, 78138, 78139, 78140, 78141, 78142, 78145, 78147, 78148, 78149, 78150, 78151, 78154, 78155, 78156, 78157, 78158, 78161, 78162, 78164, 78166, 78167, 78170, 78171, 78172, 78173, 78175, 78180, 78181, 78182, 78183, 78186, 78187, 78188, 78189, 78190, 78193, 78194, 78195, 78196, 78197, 78198, 78199, 78201, 78202, 78203, 78205, 78206, 78207, 78208, 78209, 78210, 78212, 78213, 78214, 78215, 78216, 78217, 78218, 78219, 78221, 78222, 78223, 78224, 78225, 78227, 78229, 78232, 78233, 78234, 78235, 78238, 78239, 78240, 78241, 78242, 78243, 78244, 78247, 78249, 78250, 78251, 78252, 78253, 78254, 78255, 78256, 78257, 78259, 78260, 78261, 78262, 7

UPC codes

00884838068452, 00884838098312

Source

Official record: FDA (Device enforcement) ↗

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