Philips North America: Ingenia Ambition S Model Numbers (REF): (1) 781359, (2) 782108, (3) 782133 (China ONLY), (4) 782139;

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: 611 units Lot/code info: Model Numbers (REF): (1) 781359, (2) 782108, (3) 782133 (China ONLY), (4) 782139; UDI-DI: (1) 00884838090057, (2) 00884838098343, (3) None, (4) 00884838108639; Serial Numbers: (1) 48000, 48001, 48003, 48004, 48005, 48009, 48010, 48011, 48012, 48013, 48014, 48015, 48016, 48017, 48018, 48019, 48020, 48022, 48023, 48026, 48027, 48028, 48030, 48031, 48032, 48033, 48034, 48035, 48036, 48037, 48038, 48039, 48040, 48043, 48044, 48045, 48046, 48047, 48049, 48050, 48051, 48052, 48053, 48055, 48056, 48112, 48120, 48122, 48126, 48127, 48128, 48129, 48130, 48131, 48132, 48133, 48134, 48135, 48136, 48144, 48145, 48146, 48147, 48148, 48151, 48152, 48153, 48154, 48155, 48158, 48160, 48162, 48163, 48164, 48165, 48166, 48167, 48169, 48170, 48171, 48172, 48173, 48174, 48177, 48178, 48179, 48180, 48181, 48182, 48183, 48184, 48185, 48186, 48187, 48188, 48190, 48191, 48192, 48194, 48196, 48198, 48199, 48200, 48207, 48214, 48216, 48217, 48218, 48219, 48222, 48223, 48224, 48225, 48226, 48233, 48234, 48236, 48237, 48238, 48239, 48240, 48241, 48242, 48243, 48244, 48245, 48248, 48249, 48250, 48252, 48253, 48254, 48268, 48269, 48271, 48272, 48273, 48274, 48275, 48276, 48278, 48283, 48284, 48285, 48286, 48287, 48288, 48290, 48291, 48293, 48294, 48297, 48299, 48300, 48302, 48303, 48304, 48308, 48309, 48310, 48313, 48314, 48316, 48317, 48321, 48322, 48325, 48326, 48329, 48331, 48337, (2) 48500, 48501, 48502, 48503, 48504, 48505, 48506, 48507, 48508, 48510, 48512, 48513, 48514, 48515, 48519, 48520, 48521,

UPC codes

00884838090057, 00884838098343, 00884838108639

Source

Official record: FDA (Device enforcement) ↗

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