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

Reason: 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.

Code information: 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, 48522, 48523, 48524, 48525, 48526, 48529, 48530, 48532, 48533, 48534, 48535, 48536, 48537, 48538, 48539, 48540, 48541, 48544, 48546, 48548, 48549, 48550, 48551, 48552, 48554, 48555, 48556, 48557, 48558, 48560, 48561, 48562, 48564, 48566, 48567, 48568, 48569, 48570, 48571, 48572, 48573, 48574, 48576, 48577, 48578, 48579, 48580, 48581, 48582, 48584, 48585, 48586, 48588, 48589, 48590, 48591, 48592, 48593, 48594, 48595, 48596, 48597, 48600, 48602, 48604, 48606, 48607, 48608, 48609, 48610, 48611, 48612, 48613, 48614, 48615, 48616, 48617, 48620, 48621, 48622, 48624, 48627, 48628, 48632, 48635, 48638, 48639, 48640, 48641, 48642, 48644, 48645, 48646, 48647, 48648, 48649, 48650, 48651, 48652, 48653, 48654, 48655, 48656, 48658, 48659, 48660, 48661, 48662, 48663, 48664, 48665, 48666, 48667, 48668, 48669, 48671, 48672, 48673, 48674, 48675, 48676, 48679, 48680, 48685, 48686, 48687, 48688, 48692, 48693, 48694, 48695, 48696, 48697, 48698, 48699, 48700, 48706, 48707, 48708, 48710, 48711, 48712, 48714, 48715, 48718, 48719, 48721, 48724, 48725, 48726, 48728, 48729, 48734, 48737, 48738, 48744, 48746, 48748, 48749, 48751, 48753, 48754, 48756, 48762, 48763, 48765, 48768, 48769, 48773, 48774, 48775, 48778, 48781, 48782, 48783, 48784, 48785, 48790, 48791, 48793, 48794, 48800, 48801, 48804, 48806, 48807, 48810, 48813, 48814, 48817, 48818, 48819, 48820, 48824, 48826, 48827, 48828, 48831, 48833, 48834, 48837, 48842, 48843, 48845, 48846, 48847, 48848, 48850, 48851, 48852, 48854, 48855, 48857, 48860, 48861, 48864, 48867, 48868, 48869, 48870, 48872, 48874, 48875, 48876, 48877, 48878, 48879, 48882, 48883, 48884, 48885, 48886, 48887, 48888, 48889, 48891, 48892, 48893, 48895, 48896, 48897, 48898, 48900, 48901, 48902, 48903, 48907, 48908, 48909, 48912, 48914, 48915, 48917, 48918, 48919, 48921, 48922, 48925, 48926, 48927, 48928, 48929, 48931, 48932, 48933, 48935, 48936, 48939, 48940, 48941, 48942, 48943, 48945, 48947, 48948, 48951, 48953, (3) 27500, 27502, 27504, 27505, 27506, 27507, 27508, 27509, 27511, 27512, 27514, 27515, 27516, 27517, 27518, 27519, 27520, 27521, 27522, 27523, 27524, 27525, 27526, 27527, 27528, 27529, 27530, 27531, 27532, 27533, 27534, 27535, 27536, 27537, 27538, 27539, 27541, 27542, 27543, 27544, 27545, 27547, 27548, 27551, 27552, 27553, 27554, 27555, 27556, 27558, 27560, 27566, 27567, 27568, 27570, 27571, 27572, 27573, 27574, 27575, 27576, 27579, 27580, 27581, (4) 29000, 29003, 29005, 29006, 29008, 29009, 29010, 29011, 29012, 29013, 29014, 29015, 29016, 29017, 29018, 29019, 29020, 29021, 29022, 29023, 29025, 29026, 29027, 29028, 29029, 29030, 29031, 29032, 29033, 29034, 29035, 29038, 29039, 29040, 29041, 29042, 29043, 29044, 29045, 29046, 29047, 29048, 29049, 29050, 29052, 29053, 29054, 29055, 29057, 29058, 29060, 29062, 29063, 29064, 29065, 29066, 29067, 29068, 29069, 29070, 29071, 29072, 29076, 29078, 29079, 29081, 29083, 29084, 29085, 29086, 29088, 29089, 29090, 29091, 29093, 29104, 29105, 29106, 29108, 29112, 29120, 29122;

Distribution pattern: 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.