Philips North America: Medical Device Recall in 2025 - (Recall #: Z-2209-2025)

Ingenia Ambition X Model Numbers (REF): (1) 781356, (2) 782109, (3) 782138;

Class II

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.

Model Numbers (REF): (1) 781356, (2) 782109, (3) 782138; UDI-DI: (1) 00884838090040, (2) 00884838098350, (3) 00884838108622; Serial Numbers: (1) 47000, 47001, 47002, 47003, 47004, 47006, 47007, 47009, 47011, 47012, 47013, 47014, 47015, 47016, 47017, 47018, 47019, 47020, 47021, 47022, 47023, 47024, 47025, 47026, 47027, 47028, 47029, 47030, 47032, 47033, 47034, 47035, 47037, 47038, 47039, 47040, 47041, 47043, 47044, 47045, 47047, 47048, 47049, 47050, 47051, 47052, 47053, 47054, 47056, 47057, 47058, 47059, 47060, 47061, 47062, 47063, 47064, 47065, 47066, 47067, 47068, 47070, 47071, 47072, 47074, 47075, 47077, 47078, 47080, 47081, 47082, 47083, 47084, 47085, 47088, 47089, 47090, 47091, 47092, 47093, 47094, 47095, 47096, 47097, 47098, 47099, 47173, 47174, 47175, 47176, 47177, 47183, 47184, 47185, 47187, 47188, 47189, 47190, 47192, 47193, 47194, 47195, 47196, 47197, 47198, 47199, 47200, 47202, 47203, 47204, 47205, 47206, 47207, 47208, 47209, 47210, 47211, 47215, 47216, 47219, 47220, 47221, 47222, 47225, 47226, 47227, 47230, 47231, 47233, 47237, 47242, 47244, 47245, 47248, 47251, 47252, 47253, 47254, 47255, 47258, 47260, 47262, 47264, 47268, 47269, 47270, 47271, 47272, 47274, 47275, 47276, 47278, 47279, 47280, 47281, 47282, 47283, 47284, 47286, 47288, 47289, 47290, 47291, 47292, 47294, 47297, 47298, 47299, 47301, 47302, 47303, 47304, 47305, 47306, 47307, 47309, 47310, 47311, 47312, 47313, 47314, 47315, 47316, 47322, 47323, 47324, 47325, 47328, 47329, 47330, 47331, 47332, 47333, 47335, 47336, 47337, 47338, 47339, 47340, 47341, 47342, 47344, 47345, 47346, 47347, 47348, 47350, 47351, 47352, 47353, 47356, 47357, 47361, 47364, 47365, 47367, 47370, 47371, 47372, 47377, 47378, 47380, 47382, 47384, 47385, 47387, 47506, (2) 47500, 47502, 47503, 47504, 47505, 47507, 47508, 47509, 47511, 47512, 47513, 47514, 47516, 47517, 47519, 47520, 47521, 47522, 47523, 47525, 47526, 47527, 47528, 47529, 47530, 47531, 47532, 47533, 47534, 47535, 47536, 47538, 47539, 47540, 47541, 47542, 47543, 47545, 47546, 47547, 47548, 47549, 47550, 47552, 47553, 47554, 47555, 47557, 47558, 47559, 47560, 47561, 47562, 47563, 47564, 47565, 47566, 47567, 47568, 47569, 47570, 47572, 47574, 47575, 47576, 47577, 47578, 47579, 47580, 47582, 47583, 47584, 47585, 47588, 47589, 47590, 47591, 47594, 47595, 47596, 47597, 47598, 47599, 47602, 47603, 47606, 47607, 47608, 47609, 47610, 47612, 47614, 47615, 47617, 47621, 47622, 47623, 47625, 47626, 47627, 47628, 47629, 47630, 47632, 47634, 47635, 47640, 47642, 47644, 47646, 47648, 47649, 47651, 47652, 47653, 47654, 47656, 47657, 47659, 47660, 47661, 47662, 47663, 47665, 47666, 47667, 47668, 47669, 47671, 47672, 47674, 47675, 47676, 47677, 47678, 47679, 47680, 47681, 47682, 47683, 47684, 47685, 47687, 47688, 47689, 47692, 47693, 47694, 47695, 47696, 47697, 47698, 47699, 47700, 47701, 47702, 47703, 47705, 47706, 47708, 47709, 47710, 47711, 47713, 47714, 47716, 47717, 47718, 47719, 47720, 47721, 47722, 47723, 47724, 47725, 47726, 47727, 47728, 47729, 47730, 47731, 47732, 47733, 47737, 47738, 47739, 47740, 47742, 47747, 47748, 47750, 47751, 47752, 47753, 47754, 47755, 47759, 47760, 47761, 47762, 47763, 47765, 47766, 47767, 47768, 47770, 47771, 47773, 47778, 47779, 47780, 47781, 47782, 47783, 47784, 47785, 47786, 47788, 47789, 47790, 47791, 47792, 47794, 47795, 47796, 47797, 47798, 47799, 47800, 47801, 47802, 47804, 47806, 47807, 47808, 47809, 47810, 47811, 47812, 47813, 47814, 47815, 47816, 47817, 47818, 47819, 47820, 47822, 47823, 47824, 47826, 47831, 47834, 47835, 47839, 47841, 47843, 47844, 47845, 47846, 47847, 47848, 47849, 47850, 47851, 47853, 47854, 47855, 47858, 47859, 47860, 47861, 47862, 47863, 47864, 47865, 47866, 47867, 47868, 47869, 47870, 47874, 47876, 47877, 47878, 47879, 47881, 47882, 47883, 47884, 47885, 47886, 47887, 47888, 47889, 47891, 47892, 47893, 47894, 47896, 47899, 47900, 47901, 47902, 47903, 47904, 47905, 47906, 47907, 47909, 47910, 47912, 47914, 47919, 47921, 47923, 47928, 47929, 47931, 47932, 47936, 47937, (3) 49000, 49001, 49002, 49003, 49004, 49008, 49009, 49010, 49013, 49014, 49015, 49017, 49019, 49020, 49021, 49025, 49026, 49027, 49029, 49031, 49033, 49034, 49036, 49043, 49044, 49045, 49047, 49048, 49049, 49052, 49053, 49054, 49056, 49057, 49058, 49060, 49062, 49063, 49064, 49066, 49067, 49068, 49069, 49070, 49071, 49072, 49073, 49075, 49076, 49077, 49078, 49079, 49080, 49081, 49086, 49087, 49088, 49089, 49090, 49091, 49092, 49093, 49094, 49095, 49096, 49097, 49098, 49099, 49100, 49101, 49102, 49103, 49104, 49105, 49106, 49107, 49108, 49109, 49110, 49111, 49113, 49114, 49115, 49116, 49117, 49118, 49119, 49121, 49124, 49128, 49129, 49130, 49131, 49134, 49136, 49140, 49144, 49145, 49146, 49147, 49148, 49152, 49153, 49154, 49155, 49156, 49157, 49158, 49160, 49161, 49162, 49163, 49164, 49165, 49166, 49168, 49171, 49172, 49178, 49179, 49180, 49181, 49182, 49183, 49184, 49185, 49186, 49197, 49203, 49204, 49205, 49211, 49212, 49215, 49217, 49222, 49223, 49226, 49227, 49231, 49232;

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, Finland, France, French Guiana, FrenchPolynesia, Georgia, Germany, Ghana, Greece, Guadeloupe, Guernsey, Honduras, Hong Kong, Hungary, Iceland, India, Indonesia, Iran, Iraq, Ireland, Israel, Italy, Japan, Jordan, Kazakhstan, Kenya, Kosovo, Kuwait, Kyrgyzstan, Lao, Latvia, Lebanon, Lesotho, Libya, Lithuania, Luxembourg, Macao, Macedonia, Madagascar, Malaysia, Maldives, Malta, Martinique, Mauritius, Mayotte, Mexico, Moldova, Monaco, Morocco, Myanmar, Nepal, Netherlands, New Zealand, Nicaragua, Norway, Oman, Pakistan, Palestine, Panama, Paraguay, Peru, Philippines, Poland, Portugal, Qatar, R¿union, Romania, Russian Fed., Saudi Arabia, Serbia, Singapore, Slovakia, Slovenia, South Africa, South Korea, Spain, Sri Lanka, Sweden, Switzerland, Syria, Taiwan, Tanzania, Thailand, Trinidad,Tobago, Tunisia, T¿rkiye, Turkmenistan, Ukraine, United Kingdom, Utd.Arab.Emir., Uzbekistan, Venezuela, Vietnam, Yemen, Zambia.

Voluntary: Firm initiated