FDA event 97172 · Recall Observatory

device · product 1 of 19

Achieva 3.0T; Model Numbers (REF): (1) 781177, (2) 781277, (3) 781278, (4) 781344, (5) 781345;

Z-2200-2025

Recall number: Z-2200-2025
Initiated: June 30, 2025
Classification: Class II
Status: Ongoing
Recalling firm: Philips North America
Quantity: 460 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

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.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

Compare all device evidence states

Inspect official wording and provenance

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.

Code information

Model Numbers (REF): (1) 781177, (2) 781277, (3) 781278, (4) 781344, (5) 781345; UDI-DI: (1) None, (2) None, (3) 00884838004139, (4) None, (5) None; Serial Numbers: (1) 17008, 17011, 17017, 17030, 17035, 17038, 17039, 17043, 17049, 17051, 17056, 17061, 17072, 17075, 17079, 17093, 17094, 17099, 17114, 17130, 17134, 17139, 17142, 17144, 17146, 17147, 17149, 17161, 17167, 17168, 17170, 17171, 17178, 17179, 17182, 17183, 17185, 17187, 17189, 17216, 17217, 17226, 17233, 17234, 17235, 17243, 17251, 17256, 17270, 17279, 17295, 17296, 17304, 17316, 17319, 17324, 17334, 17347, 17349, 17358, 17362, 17365, 17374, 17379, 17384, 17392, 17393, 17393, 17402, 17404, 17414, 17418, 17426, 17427, 17431, 17432, 17443, 17445, 17446, 17448, 17450, 17452, 17453, 17456, 17469, 17471, 17494, 17497, 17500, 17523, 17535, 17558, 17561, 17596, 17599, 17607, 24007, 24009, 24010, 24019, 24037, 24038, 24049, 24050, 24053, 24056, 24059, 24060, 24066, 24068, 24070, 24078, 24079, 24081, 24089, 24091, 24096, 24097, 24099, 24100, 24107, 24114, 24116, 24120, 24125, 24130, 24131, 24138, 24154, 34148, (2) 24115, 34002, 34011, 34020, 34028, 34029, 34030, 34033, 34034, 34038, 34043, 34065, 34066, 34071, 34073, 34074, 34077, 34082, 34086, 34095, 34106, 34109, 34113, 34115, 34118, 34120, 34123, 34135, 34138, 34139, 34140, 34144, 34159, 34160, 34165, 34200, 34201, 34203, 34207, 34213, 34220, 34225, 34230, 34231, 34232, 34234, 34237, 34239, 34241, 34242, 34247, 34253, 34254, 34255, 34256, 34258, 34263, 34264, 34268, 34270, 34271, 34272, 34273, 34274, 34275, 34276, 34281, 34282, 34285, 34286, 34287, 34288, 34289, 34290, 34291, 34293, 34294, 34295, 34297, 34298, 34299, 34300, 34301, 34305, 34306, 34309, 34311, 73012, (3) 38002, 38003, 38007, 38012, 38017, 38018, 38021, 38022, 38033, 38034, 38043, 38044, 38047, 38054, 38055, 38056, 38057, 38059, 38060, 38061, 38064, 38069, 38072, 38079, 38085, 38086, 38087, 38090, 38091, 38093, 38095, 38098, 38099, 38103, 38104, 38108, 38112, 38115, 38130, 38133, 38137, 38139, 38140, 38141, 38143, 38144, 38145, 38150, 38151, 38152, 38157, 38158, 38160, 38167, 38169, 38171, 38173, 38174, 38181, 38185, 38186, 38187, 38188, 38190, 38191, 38194, 38196, 38200, 38206, 38207, 38209, 38210, 38212, 38215, 38216, 38220, 38223, 38227, 38228, 38229, 38231, 38232, 38233, 38236, 38238, 38240, 38241, 38245, 38246, 38247, 38248, 38249, 38251, 38252, 38253, 38254, 38255, 38256, 38257, 38258, 38260, 38261, 38262, 38264, 38265, 38266, 38267, 38268, 38269, 38270, 38271, 38272, 38273, 38274, 38276, 38278, 38279, 38280, 38282, 38283, 38284, 38287, 38288, 38291, 38292, 38293, 38295, 38296, 38297, 38298, 38299, 38302, 38303, 38304, 38307, 38312, 38314, 38315, 38318, 38319, 38320, 38321, 38322, 38323, 38324, 38326, 38327, 38328, 38329, 38330, 38331, 38332, 38335, 38337, 38338, 38339, 38340, 38341, 38343, 38344, 38345, 38346, 38347, 38349, 38351, 38355, 38358, 38359, 38360, 38361, 38363, 38367, 38368, 38370, 38372, 38401, 38402, 38405, 38407, 38408, 38410, 38412, 38414, 38415, 38420, 38421, 38423, 38424, 38425, 38426, 38427, 38429, 38430, 38431, 38432, 38433, 38436, 38437, 38438, 38439, 38441, 38442, 38443, 38445, 38447, 38448, 38450, 38453, 38454, 38456, 38457, 38458, 382320, (4) 73003, 73005, 73006, 73008, 73009, 73010, (5) 74001, 74005, 74007, 74009, 74010, 74020, 74021, 74026, 74027, 74029, 74030, 74032, 74033, 74034, 74035, 74037, 74039, 74041, 74044, 74046, 74047, 74048, 74052;

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.

device · product 2 of 19

Achieva XR; Model Numbers (REF): (1) 781153, (2) 781253;

Z-2201-2025

Recall number: Z-2201-2025
Initiated: June 30, 2025
Classification: Class II
Status: Ongoing
Recalling firm: Philips North America
Quantity: 40 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

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.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

Compare all device evidence states

Inspect official wording and provenance

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.

Code information

Model Numbers (REF): (1) 781153, (2) 781253; UDI-DI: (1) None, (2) None; Serial Numbers: (1) 23003, 23004, 23005, 23011, 23014, 23017, 23020, 23021, 23028, 23031, 23035, 23041, 34039, (2) 35004, 35006, 35007, 35011, 35015, 35016, 35019, 35020, 35021, 35022, 35028, 35035, 35049, 35050, 35061, 35063, 35067, 35068, 35069, 35070, 35074, 35075, 35076, 35081, 35083, 35084, 35085;

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.

device · product 3 of 19

Evolution Upgrade 1.5T Model Numbers (REF): (1) 782116, (2) 782148;

Z-2202-2025

Recall number: Z-2202-2025
Initiated: June 30, 2025
Classification: Class II
Status: Ongoing
Recalling firm: Philips North America
Quantity: 93 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

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.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

Compare all device evidence states

Inspect official wording and provenance

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.

Code information

Model Numbers (REF): (1) 782116, (2) 782148; UDI-DI: (1) 00884838099722, (2) 00884838108714; Serial Numbers: (1) 41017, 41024, 41025, 41041, 41042, 41047, 41051, 41080, 41089, 41130, 41139, 41143, 41144, 41179, 41189, 41196, 41226, 41229, 41235, 41286, 41287, 41295, 41311, 41327, 41344, 41349, 41367, 41413, 41424, 41432, 41433, 41457, 41491, 41497, 41520, 41527, 41568, 70068, 70093, 70099, 70190, 70202, 70205, 70260, 70284, 70589, 70630, 70696, 70949, 70995, 70996, 81021, 81073, 84370, 84741, (2) 41011, 41031, 41182, 41244, 41277, 41284, 41334, 41392, 41427, 41446, 41464, 41488, 41523, 41534, 41547, 70067, 70289, 70452, 70454, 70473, 70590, 70596, 70622, 70644, 70652, 70742, 70769, 70803, 70829, 70966, 70980, 70983, 84102, 84109, 84368, 84435, 84630, 84825,

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.

device · product 4 of 19

Evolution Upgrade 3.0T Model Numbers (REF): (1) 782117, (2) 782143;

Z-2203-2025

Recall number: Z-2203-2025
Initiated: June 30, 2025
Classification: Class II
Status: Ongoing
Recalling firm: Philips North America
Quantity: 50 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

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.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

Compare all device evidence states

Inspect official wording and provenance

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.

Code information

Model Numbers (REF): (1) 782117, (2) 782143; UDI-DI: (1) 00884838099739, (2) 00884838108660; Serial Numbers: (1) 42003, 42023, 42024, 42029, 42078, 42217, 42246, 42375, 42402, 42408, 71044, 71348, 71774, 85146, 85645, 85663, 85668, 85675, 85677, 85680, 85685, 85687, 85694, 85698, 85705, 85713, (2) 3, 42069, 42193, 42225, 42308, 42320, 42366, 42415, 71595, 71815, 71836, 85649, 85651, 85682, 85683, 85684, 85688, 85690, 85695, 85697, 85699, 85701, 85708, 85714;

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.

device · product 5 of 19

Ingenia 1.5T Model Numbers (REF): (1) 781315, (2) 718641, (3) 781396, (4) 782101, (5) 782115, (6) 782140;

Z-2204-2025

Recall number: Z-2204-2025
Initiated: June 30, 2025
Classification: Class II
Status: Ongoing
Recalling firm: Philips North America
Quantity: 2,279 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

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.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

Compare all device evidence states

Inspect official wording and provenance

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.

Code information

Model Numbers (REF): (1) 781315, (2) 718641, (3) 781396, (4) 782101, (5) 782115, (6) 782140; UDI-DI: (1) 00884838099715, (2) 00884838055322, (3) 00884838009820, (4) 00884838098275, (5) 00884838099043, (6) 00884838108646; Serial Numbers: (1) 61000, 61001, 61002, 61003, 61004, 61005, 61006, 61007, 61008, 61009, 61011, 61013, 61014, 61015, 61016, 61017, 61018, 61019, 61020, 61022, 61023, 61024, 61025, 61026, 61027, 61028, 61029, 61030, 61031, 61032, 61033, 61034, 61035, 61036, 61037, 61038, 61039, 61040, 61041, 61042, 61043, 61044, 61045, 61046, 61047, 61049, 61050, 61051, 61052, 61053, 61054, 61055, 61056, 61057, 61058, 61059, 61060, 61061, 61062, 61063, 61064, 61065, 61066, 61067, 61068, 61069, 61070, 61072, 61073, 61074, 61075, 61076, 61078, 61079, 61080, 61082, 61084, 61085, 61087, 61088, 61091, 61092, 61093, 61094, 61095, 61096, 61097, 61101, 61102, 61103, 61105, 61106, 61107, 61108, 61109, 61112, 61114, 61115, 61116, 61117, 61119, 61123, 61124, 61125, 61126, 61129, 61130, 61131, 61132, 61138, 61140, 61142, 61143, 61144, (2) 70009, 70011, 70013, 70018, 70021, 70022, 70025, 70026, 70027, 70029, 70032, 70037, 70038, 70039, 70040, 70042, 70044, 70046, 70048, 70049, 70050, 70051, 70052, 70053, 70055, 70056, 70057, 70058, 70059, 70062, 70063, 70064, 70065, 70066, 70071, 70072, 70073, 70074, 70075, 70076, 70080, 70084, 70085, 70087, 70088, 70092, 70094, 70095, 70097, 70101, 70104, 70110, 70111, 70113, 70114, 70119, 70122, 70123, 70128, 70129, 70131, 70135, 70136, 70140, 70142, 70144, 70146, 70148, 70154, 70155, 70156, 70157, 70160, 70161, 70177, 70179, 70191, 70192, 70194, 70195, 70196, 70198, 70199, 70200, 70201, 70203, 70204, 70206, 70221, 70223, 70225, 70226, 70227, 70228, 70229, 70230, 70232, 70233, 70235, 70236, 70238, 70242, 70244, 70245, 70246, 70249, 70250, 70251, 70255, 70257, 70258, 70259, 70261, 70262, 70263, 70264, 70269, 70270, 70271, 70273, 70277, 70278, 70279, 70280, 70281, 70282, 70285, 70286, 70287, 70290, 70292, 70294, 70295, 70296, 70297, 70298, 70299, 70300, 70301, 70302, 70303, 70306, 70308, 70311, 70312, 70313, 70314, 70316, 70318, 70321, 70328, 70329, 70333, 70334, 70335, 70337, 70339, 70343, 70344, 70346, 70347, 70348, 70349, 70350, 70351, 70356, 70357, 70358, 70359, 70360, 70361, 70364, 70367, 70368, 70369, 70371, 70374, 70375, 70376, 70379, 70381, 70383, 70384, 70401, 70402, 70403, 70405, 70407, 70416, 70423, 70424, 70425, 70426, 70427, 70428, 70429, 70432, 70434, 70435, 70436, 70437, 70438, 70439, 70440, 70441, 70442, 70443, 70444, 70445, 70446, 70447, 70448, 70449, 70451, 70453, 70455, 70456, 70459, 70460, 70461, 70463, 70464, 70465, 70468, 70470, 70471, 70472, 70480, 70481, 70482, 70483, 70485, 70486, 70487, 70488, 70489, 70490, 70583, 70585, 70587, 70588, 70591, 70592, 70593, 70595, 70597, 70598, 70599, 70601, 70603, 70604, 70605, 70606, 70607, 70608, 70610, 70611, 70612, 70613, 70614, 70615, 70617, 70619, 70621, 70623, 70624, 70626, 70627, 70628, 70629, 70635, 70636, 70637, 70638, 70641, 70642, 70645, 70646, 70647, 70648, 70649, 70650, 70651, 70654, 70655, 70656, 70657, 70658, 70659, 70660, 70661, 70662, 70663, 70664, 70665, 70666, 70667, 70668, 70670, 70672, 70673, 70674, 70675, 70676, 70677, 70678, 70679, 70680, 70682, 70683, 70684, 70685, 70686, 70689, 70690, 70691, 70692, 70693, 70694, 70695, 70697, 70698, 70699, 70700, 70701, 70702, 70703, 70704, 70705, 70706, 70707, 70708, 70709, 70710, 70711, 70712, 70714, 70715, 70717, 70719, 70720, 70722, 70723, 70724, 70725, 70726, 70727, 70728, 70729, 70730, 70732, 70733, 70734, 70735, 70736, 70738, 70741, 70743, 70744, 70745, 70746, 70747, 70749, 70750, 70751, 70752, 70754, 70755, 70758, 70759, 70760, 70761, 70762, 70763, 70764, 70765, 70767, 70768, 70770, 70771, 70772, 70773, 70774, 70775, 70776, 70777, 70778, 70779, 70780, 70783, 70784, 70785, 70786, 70787, 70788, 70789, 70791, 70792, 70793, 70794, 70795, 70796, 70797, 70798, 70799, 70800, 70801, 70802, 70804, 70805, 70806, 70808, 70809, 70810, 70811, 70812, 70813, 70815, 70817, 70818, 70819, 70820, 70821, 70823, 70824, 70825, 70826, 70827, 70828, 70830, 70831, 70832, 70833, 70834, 70835, 70836, 70839, 70840, 70841, 70843, 70844, 70845, 70846, 70847, 70848, 70849, 70850, 70851, 70854, 70855, 70857, 70858, 70859, 70861, 70862, 70863, 70864, 70865, 70866, 70867, 70868, 70869, 70870, 70871, 70872, 70873, 70874, 70875, 70876, 70878, 70880, 70881, 70882, 70883, 70885, 70886, 70887, 70888, 70889, 70890, 70891, 70892, 70893, 70894, 70896, 70897, 70898, 70899, 70900, 70902, 70903, 70904, 70906, 70908, 70909, 70910, 70911, 70914, 70915, 70916, 70917, 70918, 70919, 70920, 70921, 70922, 70923, 70926, 70927, 70928, 70929, 70930, 70931, 70932, 70933, 70934, 70935, 70937, 70939, 70941, 70942, 70943, 70945, 70946, 70947, 70948, 70951, 70952, 70953, 70954, 70957, 70960, 70961, 70962, 70963, 70965, 70969, 70970, 70971, 70972, 70973, 70974, 70975, 70976, 70977, 70979, 70981, 70982, 70985, 70986, 70987, 70988, 70989, 70990, 70991, 70992, 70993, 70994, 70997, 70998, 84002, 84003, 84004, 84005, 84007, 84008, 84010, 84012, 84013, 84015, 84016, 84017, 84018, 84021, 84025, 84026, 84027, 84028, 84029, 84030, 84031, 84032, 84034, 84035, 84036, 84037, 84038, 84039, 84042, 84043, 84045, 84046, 84047, 84048, 84049, 84051, 84052, 84057, 84060, 84061, 84062, 84063, 84065, 84066, 84067, 84068, 84069, 84070, 84074, 84075, 84076, 84077, 84079, 84080, 84081, 84082, 84083, 84084, 84085, 84086, 84087, 84088, 84089, 84091, 84092, 84093, 84095, 84096, 84098, 84099, 84104, 84107, 84108, 84110, 84113, 84114, 84115, 84116, 84118, 84122, 84124, 84125, 84126, 84127, 84129, 84130, 84131, 84134, 84135, 84136, 84137, 84138, 84140, 84141, 84142, 84144, 84145, 84147, 84148, 84149, 84150, 84153, 84154, 84155, 84157, 84162, 84164, 84165, 84166, 84167, 84168, 84169, 84170, 84171, 84172, 84173, 84174, 84175, 84176, 84177, 84178, 84179, 84180, 84181, 84184, 84185, 84186, 84187, 84189, 84191, 84192, 84193, 84194, 84195, 84196, 84197, 84198, 84199, 84200, 84201, 84202, 84203, 84204, 84205, 84206, 84207, 84208, 84209, 84210, 84211, 84212, 84214, 84216, 84217, 84218, 84219, 84220, 84221, 84222, 84225, 84226, 84228, 84229, 84230, 84231, 84233, 84234, 84237, 84239, 84240, 84241, 84242, 84243, 84244, 84245, 84247, 84248, 84249, 84251, 84252, 84253, 84254, 84255, 84256, 84257, 84258, 84259, 84261, 84262, 84264, 84266, 84267, 84268, 84269, 84270, 84271, 84272, 84274, 84275, 84276, 84278, 84279, 84280, 84281, 84282, 84283, 84286, 84287, 84288, 84289, 84290, 84291, 84292, 84293, 84294, 84295, 84297, 84298, 84300, 84302, 84303, 84305, 84306, 84307, 84308, 84309, 84310, 84311, 84312, 84313, 84314, 84315, 84316, 84318, 84319, 84320, 84321, 84322, 84323, 84325, 84327, 84328, 84329, 84330, 84331, 84332, 84333, 84334, 84335, 84338, 84339, 84340, 84341, 84342, 84343, 84344, 84346, 84347, 84349, 84350, 84351, 84352, 84353, 84354, 84355, 84357, 84359, 84360, 84361, 84362, 84363, 84367, 84369, 84371, 84372, 84374, 84375, 84376, 84377, 84378, 84379, 84380, 84381, 84382, 84383, 84384, 84385, 84387, 84388, 84389, 84392, 84394, 84395, 84396, 84397, 84398, 84399, 84400, 84401, 84402, 84403, 84404, 84407, 84408, 84409, 84410, 84411, 84412, 84413, 84414, 84415, 84416, 84417, 84419, 84420, 84421, 84422, 84423, 84424, 84425, 84427, 84428, 84429, 84430, 84431, 84432, 84433, 84434, 84437, 84438, 84439, 84440, 84441, 84443, 84444, 84445, 84446, 84448, 84450, 84451, 84452, 84453, 84454, 84455, 84456, 84458, 84459, 84460, 84462, 84467, 84469, 84470, 84471, 84472, 84473, 84474, 84475, 84476, 84477, 84479, 84480, 84481, 84482, 84483, 84484, 84485, 84487, 84488, 84489, 84490, 84491, 84492, 84494, 84495, 84496, 84497, 84498, 84499, 84500, 84502, 84503, 84505, 84506, 84507, 84508, 84509, 84510, 84512, 84513, 84514, 84515, 84516, 84517, 84518, 84519, 84520, 84521, 84522, 84523, 84524, 84525, 84526, 84527, 84528, 84529, 84530, 84531, 84532, 84533, 84534, 84535, 84536, 84537, 84538, 84539, 84541, 84542, 84544, 84545, 84546, 84547, 84549, 84550, 84551, 84552, 84555, 84556, 84557, 84558, 84560, 84564, 84565, 84566, 84568, 84569, 84571, 84572, 84573, 84574, 84575, 84576, 84577, 84581, 84582, 84583, 84584, 84585, 84587, 84588, 84591, 84592, 84593, 84594, 84596, 84597, 84598, 84599, 84600, 84602, 84603, 84604, 84605, 84606, 84608, 84611, 84612, 84613, 84614, 84616, 84617, 84620, 84621, 84624, 84626, 84627, 84629, 84632, 84633, 84634, 84635, 84637, 84640, 84641, 84642, 84644, 84645, 84646, 84647, 84648, 84649, 84650, 84651, 84652, 84653, 84654, 84655, 84656, 84657, 84659, 84660, 84661, 84662, 84663, 84664, 84666, 84667, 84668, 84669, 84670, 84671, 84673, 84674, 84675, 84676, 84677, 84678, 84679, 84680, 84681, 84682, 84686, 84687, 84689, 84690, 84692, 84693, 84694, 84695, 84697, 84700, 84704, 84705, 84706, 84708, 84709, 84712, 84713, 84714, 84716, 84717, 84718, 84719, 84720, 84721, 84722, 84723, 84724, 84725, 84726, 84729, 84730, 84733, 84734, 84736, 84738, 84740, 84742, 84744, 84745, 84746, 84747, 84748, 84750, 84751, 84752, 84755, 84756, 84757, 84758, 84759, 84765, 84766, 84767, 84768, 84770, 84771, 84772, 84773, 84774, 84775, 84776, 84777, 84778, 84779, 84780, 84781, 84782, 84783, 84787, 84788, 84789, 84790, 84791, 84792, 84793, 84795, 84796, 84798, 84799, 84801, 84802, 84803, 84804, 84805, 84806, 84807, 84808, 84809, 84810, 84811, 84812, 84813, 84816, 84818, 84819, 84820, 84821, 84822, 84823, 84824, 84826, 84827, 84828, 84829, 84830, 84831, 84832, 84833, 84834, 84836, 84837, 84838, 84839, 84840, 84842, 84844, 84845, 84847, 84848, 84849, 84850, 84851, 84852, 84853, 84854, 84855, 84857, 84858, 84859, 84861, 84862, 84863, 84864, 84865, 84866, 84867, 84868, 84869, 84871, 84872, 84873, 84879, 84880, 84881, 84882, 84885, 84888, 84889, 84890, 84891, 84892, 84893, 84894, 84895, 84896, 84900, 84901, 84904, 84905, 84908, 84909, 84910, 84911, 84913, 84914, 84915, 84916, 84917, 84918, 84920, 84921, 84922, 84928, 84929, 84930, 84931, 84933, 84934, 84935, 84937, 84939, 84940, 84942, 84943, 84946, 84947, 84948, 84952, 84954, 84955, 84956, 84960, 84965, 84969, 84970, 84973, 84975, 84976, 84977, 84978, 84979, 84982, 84983, 84984, 84986, 84987, 84988, 84989, 84990, 84993, 84994, 84995, 84996, 84997, 87000, 87001, 87003, 87004, 87005, 87008, 87009, 87017, 87019, 87022, 87023, 87024, 87026, 87027, 87028, 87029, 87031, 87034, 87035, 87036, 87037, 87038, 87039, 87040, 87043, 87044, 87045, 87048, 87049, 87050, 87054, 87055, 87056, 87057, 87058, 87059, 87061, 87062, 87065, 87066, 87067, 87068, 87069, 87071, 87076, 87078, 87079, 87081, 87082, 87083, 87084, 87086, 87087, 87090, 87092, 87093, 87094, 87095, 87097, 87098, 87100, 87101, 87102, 87103, 87109, 87110, 87111, 87112, 87113, 87114, 87115, 87116, 87117, 87119, 87120, 87121, 87123, 87124, 87125, 87126, 87129, 87131, 87132, 87133, 87134, 87135, 87136, 87138, 87139, 87141, 87142, 87143, 87144, 87146, 87147, 87151, 87152, 87153, 87154, 87155, 87158, 87161, 87163, 87165, 87171, 87172, 87174, 87175, 87176, 87177, 87180, 87181, 87185, 87187, 87188, 87190, 87191, 87192, 87194, 87195, 87196, 87197, 87201, 87202, 87204, 87206, 87207, 87208, 87209, 87210, 87211, 87212, 87213, 87214, 87215, 87218, 87219, 87221, 87222, 87224, 87226, 87227, 87228, 87229, 87231, 87232, 87233, 87234, 87235, 87236, 87237, 87238, 87239, 87240, 87241, 87242, 87244, 87245, 87247, 87248, 87249, 87252, 87253, 87254, 87255, 87257, 87259, 87260, 87262, 87265, 87266, 87268, 87269, 87271, 87272, 87274, 87276, 87277, 87278, 87279, 87280, 87281, 87282, 87283, 87284, 87285, 87289, 87290, 87291, 87293, 87294, 87296, 87297, 87299, 87300, 87302, 87303, 87305, 87307, 87311, 87312, 87314, 87315, 87317, 87318, 87319, 87320, 87326, (3) 41000, 41001, 41002, 41003, 41005, 41006, 41007, 41008, 41009, 41010, 41012, 41013, 41015, 41016, 41018, 41020, 41021, 41022, 41023, 41026, 41028, 41029, 41033, 41034, 41035, 41037, 41039, 41043, 41044, 41045, 41046, 41048, 41049, 41050, 41052, 41055, 41056, 41057, 41059, 41060, 41061, 41066, 41067, 41068, 41070, 41071, 41073, 41074, 41075, 41077, 41079, 41083, 41084, 41085, 41086, 41087, 41088, 41090, 41091, 41092, 41093, 41094, 41095, 41096, 41097, 41098, 41099, 41100, 41103, 41105, 41106, 41107, 41108, 41109, 41110, 41111, 41112, 41113, 41115, 41116, 41117, 41118, 41119, 41120, 41123, 41124, 41125, 41126, 41127, 41128, 41129, 41131, 41132, 41133, 41134, 41136, 41137, 41138, 41140, 41141, 41142, 41145, 41146, 41148, 41149, 41151, 41152, 41153, 41154, 41157, 41158, 41160, 41161, 41162, 41163, 41164, 41166, 41168, 41169, 41171, 41172, 41174, 41175, 41176, 41177, 41178, 41180, 41181, 41184, 41185, 41186, 41188, 41190, 41191, 41192, 41193, 41194, 41195, 41197, 41198, 41199, 41200, 41201, 41202, 41203, 41204, 41205, 41206, 41208, 41209, 41210, 41211, 41212, 41213, 41214, 41215, 41216, 41217, 41218, 41219, 41220, 41221, 41222, 41224, 41225, 41228, 41230, 41231, 41232, 41233, 41234, 41236, 41237, 41238, 41239, 41240, 41241, 41242, 41243, 41246, 41249, 41250, 41251, 41253, 41254, 41255, 41256, 41257, 41258, 41259, 41260, 41261, 41262, 41263, 41265, 41266, 41267, 41268, 41271, 41272, 41278, 41279, 41280, 41281, 41282, 41283, 41288, 41289, 41290, 41292, 41293, 41294, 41296, 41298, 41299, 41300, 41301, 41302, 41303, 41304, 41305, 41306, 41309, 41310, 41312, 41313, 41314, 41318, 41319, 41330, 41331, 41332, 41335, 41336, 41337, 41338, 41340, 41342, 41343, 41350, 41351, 41352, 41354, 41355, 41356, 41357, 41358, 41359, 41361, 41362, 41363, 41364, 41365, 41366, 41368, 41370, 41371, 41373, 41376, 41380, 41381, 41383, 41384, 41387, 41388, 41389, 41394, 41395, 41397, 41398, 41399, 41400, 41402, 41405, 41406, 41407, 41408, 41409, 41412, 41414, 41415, 41417, 41418, 41419, 41420, 41421, 41422, 41423, 41426, 41428, 41429, 41434, 41435, 41436, 41437, 41440, 41441, 41442, 41449, 41450, 41452, 41453, 41454, 41456, 41458, 41459, 41460, 41461, 41462, 41463, 41465, 41466, 41467, 41470, 41471, 41473, 41474, 41475, 41476, 41477, 41478, 41479, 41480, 41481, 41482, 41484, 41485, 41486, 41489, 41492, 41493, 41494, 41495, 41496, 41498, 41499, 41500, 41502, 41505, 41507, 41509, 41511, 41512, 41513, 41514, 41515, 41516, 41517, 41518, 41519, 41521, 41522, 41524, 41525, 41526, 41531, 41532, 41535, 41536, 41538, 41540, 41543, 41544, 41545, 41546, 41548, 41549, 41551, 41552, 41553, 41555, 41556, 41558, 41559, 41560, 41561, 41562, 41563, 41564, 41565, 41569, 41570, 41571, 41572, 41573, 41574, 41575, 41578, 41580, 41583, 41584, 41588, 41590, 41591, 41592, 41594, 41595, 41610, 41612, 41615, 41617, 41618, 41619, 87203, 413020, 413430, (4) 87298, 87601, 87602, 87605, 87607, 87608, 87609, 87610, 87612, 87613, 87614, 87615, 87617, 87622, 87625, 87627, 87631, 87632, 87633, 87634, 87635, 87636, 87637, 87638, 87639, 87640, 87641, 87642, 87643, 87644, 87645, 87648, 87649, 87651, 87653, 87654, 87655, (5) 61145, 61175, 61176, 61177, 61178, 61179, 61180, 61181, 61182, 61183, 61184, 61185, 61186, 61187, 61188, 61189, 61191, 61192, 61193, 61195, 61198, 61199, 61200, 61201, 61202, 61203, 61204, 61205, 61206, 61207, 61208, 61209, 61210, 61211, 61212, 61213, 61214, 61216, 61217, 61218, 61219, 61220, 61221, 61222, 61223, 61224, 61225, 61226, 61227, 61228, 61229, 61230, 61231, 61232, 61233, 61234, 61235, 61236, 61237, 61238, 61240, 61241, 61242, 61243, 61245, 61246, 61248, 61249, 61250, 61252, 61253, 61256, 61257, 61258, 61259, 61260, 61261, 61262, 61263, 61264, 61265, 61266, 61268, 61269, 61270, 61271, 61272, 61273, 61274, 61275, 61276, 61279, 61280, 61281, 61282, 61283, 61284, 61285, 61286, 61287, 61288, 61289, 61290, 61291, 61292, 61293, 61294, 61295, 61298, 61299, 61300, 61302, 61303, 61304, 61306, 61310, 61311, 61312, 61313, 61314, 61315, 61316, 61317, 61319, 61320, 61321, 61326, 61327, 61328, 61329, 61330, 61331, 61332, 61333, 61334, 61336, 61337, 61338, 61339, 61341, 61342, 61348, 61349, 61350, 61351, 61352, 61354, 61355, 61356, 61357, 61358, 61359, 61360, 61361, 61362, 61363, 61364, 61365, 61366, 61367, 61368, 61369, 61370, 61371, 61372, 61373, 61374, 61375, 61376, 61377, 61378, 61380, 61381, 61382, 61383, 61384, 61385, 61386, 61387, 61388, 61390, 61393, 61394, 61395, 61396, 61397, 61398, 61399, 61400, 61401, 61402, 61403, 61404, 61406, 61407, 61408, 61409, 61410, 61411, 61412, 61413, 61415, 61416, 61417, 61418, 61419, 61420, 61421, 61422, 61425, 61426, 61427, 61428, 61430, (6) 45601, 45602, 45606, 45607, 45608, 45609;

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.

device · product 6 of 19

Ingenia 1.5T S Model Number (REF): 781347;

Z-2205-2025

Recall number: Z-2205-2025
Initiated: June 30, 2025
Classification: Class II
Status: Ongoing
Recalling firm: Philips North America
Quantity: 136 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

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.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

Compare all device evidence states

Inspect official wording and provenance

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.

Code information

Model Number (REF): 781347; UDI-DI: 00884838068421; Serial Numbers: 81001, 81003, 81004, 81005, 81006, 81007, 81008, 81009, 81010, 81011, 81013, 81014, 81015, 81016, 81017, 81018, 81019, 81020, 81023, 81024, 81025, 81027, 81028, 81029, 81030, 81031, 81032, 81033, 81034, 81035, 81037, 81038, 81040, 81041, 81042, 81043, 81044, 81045, 81046, 81047, 81048, 81049, 81050, 81051, 81052, 81055, 81056, 81058, 81059, 81060, 81061, 81062, 81063, 81064, 81065, 81067, 81070, 81071, 81072, 81074, 81075, 81076, 81077, 81078, 81079, 81080, 81084, 81085, 81086, 81087, 81088, 81090, 81091, 81092, 81093, 81094, 81095, 81096, 81097, 81098, 81103, 81105, 81106, 81108, 81111, 81112, 81113, 81114, 81115, 81116, 81117, 81118, 81122, 81123, 81124, 81126, 81127, 81128, 81129, 81131, 81132, 81133, 81137, 81138, 81139, 81140, 81145, 81146, 81147, 81148, 81149, 81151, 81152, 81153, 81154, 81155, 81156, 81157, 81158, 81159, 81162, 81164, 81165, 81167, 81170, 81171, 81172, 81173, 81174, 81175, 81176, 81178, 81179, 81180, 81184, 81185;

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.

device · product 7 of 19

Ingenia 3.0T Model Numbers (REF): (1) 781342, (2) 781377, (3) 782103;

Z-2206-2025

Recall number: Z-2206-2025
Initiated: June 30, 2025
Classification: Class II
Status: Ongoing
Recalling firm: Philips North America
Quantity: 1,467 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

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.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

Compare all device evidence states

Inspect official wording and provenance

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.

Code information

Model Numbers (REF): (1) 781342, (2) 781377, (3) 782103; UDI-DI: (1) 00884838055339, (2) 00884838009813, (3) 00884838098299; Serial Numbers: (1) 71001, 71002, 71003, 71004, 71006, 71007, 71008, 71010, 71011, 71012, 71013, 71014, 71016, 71018, 71020, 71022, 71023, 71026, 71027, 71029, 71031, 71035, 71037, 71038, 71039, 71040, 71045, 71047, 71051, 71055, 71056, 71058, 71060, 71061, 71062, 71064, 71065, 71068, 71070, 71071, 71072, 71073, 71074, 71077, 71078, 71081, 71084, 71086, 71087, 71088, 71089, 71093, 71095, 71097, 71101, 71106, 71107, 71150, 71152, 71153, 71154, 71155, 71156, 71157, 71159, 71162, 71163, 71164, 71165, 71166, 71168, 71170, 71172, 71173, 71174, 71175, 71176, 71177, 71179, 71181, 71183, 71184, 71185, 71187, 71188, 71189, 71190, 71192, 71193, 71194, 71195, 71197, 71198, 71200, 71203, 71204, 71208, 71210, 71211, 71213, 71214, 71215, 71216, 71220, 71224, 71225, 71227, 71228, 71231, 71252, 71260, 71262, 71263, 71266, 71267, 71268, 71269, 71270, 71271, 71272, 71275, 71276, 71277, 71279, 71280, 71282, 71283, 71285, 71286, 71287, 71288, 71290, 71291, 71296, 71297, 71298, 71299, 71300, 71301, 71302, 71303, 71304, 71305, 71307, 71308, 71309, 71311, 71312, 71313, 71314, 71315, 71317, 71318, 71319, 71320, 71321, 71322, 71323, 71324, 71326, 71327, 71328, 71329, 71331, 71332, 71333, 71334, 71335, 71336, 71337, 71338, 71339, 71340, 71341, 71342, 71343, 71344, 71345, 71346, 71347, 71349, 71350, 71351, 71352, 71353, 71354, 71355, 71356, 71357, 71358, 71359, 71360, 71361, 71362, 71363, 71364, 71365, 71367, 71368, 71369, 71370, 71371, 71372, 71373, 71374, 71375, 71376, 71377, 71378, 71379, 71380, 71381, 71382, 71384, 71385, 71386, 71387, 71388, 71389, 71390, 71392, 71393, 71394, 71395, 71396, 71397, 71398, 71399, 71400, 71401, 71402, 71403, 71405, 71406, 71407, 71408, 71409, 71410, 71411, 71412, 71413, 71414, 71415, 71416, 71418, 71419, 71420, 71422, 71423, 71424, 71425, 71426, 71427, 71428, 71429, 71433, 71434, 71436, 71437, 71438, 71440, 71441, 71442, 71443, 71444, 71445, 71446, 71448, 71449, 71450, 71451, 71452, 71453, 71456, 71457, 71459, 71460, 71461, 71462, 71463, 71464, 71465, 71467, 71468, 71470, 71471, 71472, 71473, 71474, 71475, 71476, 71477, 71478, 71479, 71480, 71481, 71482, 71483, 71484, 71485, 71486, 71487, 71489, 71490, 71491, 71492, 71493, 71495, 71496, 71497, 71498, 71499, 71501, 71505, 71506, 71509, 71510, 71511, 71512, 71513, 71514, 71516, 71517, 71518, 71519, 71520, 71521, 71522, 71524, 71526, 71527, 71529, 71532, 71534, 71541, 71544, 71545, 71548, 71550, 71551, 71553, 71554, 71555, 71556, 71557, 71558, 71559, 71560, 71562, 71563, 71564, 71565, 71566, 71567, 71569, 71570, 71571, 71574, 71575, 71576, 71577, 71580, 71581, 71582, 71583, 71584, 71587, 71588, 71589, 71590, 71592, 71594, 71596, 71597, 71599, 71600, 71601, 71602, 71603, 71604, 71605, 71607, 71608, 71609, 71610, 71614, 71615, 71616, 71618, 71619, 71620, 71621, 71622, 71623, 71624, 71625, 71626, 71628, 71629, 71630, 71631, 71633, 71634, 71635, 71637, 71639, 71640, 71641, 71642, 71643, 71644, 71645, 71646, 71647, 71648, 71649, 71650, 71651, 71652, 71653, 71654, 71655, 71656, 71658, 71659, 71660, 71662, 71665, 71667, 71668, 71669, 71670, 71671, 71673, 71674, 71675, 71676, 71677, 71678, 71679, 71680, 71681, 71682, 71683, 71684, 71685, 71686, 71687, 71688, 71689, 71690, 71691, 71692, 71693, 71694, 71695, 71697, 71698, 71699, 71700, 71702, 71703, 71704, 71706, 71707, 71708, 71709, 71710, 71711, 71713, 71714, 71715, 71716, 71717, 71721, 71722, 71723, 71725, 71726, 71729, 71730, 71732, 71733, 71734, 71735, 71737, 71738, 71739, 71740, 71742, 71743, 71744, 71745, 71746, 71748, 71749, 71750, 71751, 71752, 71754, 71755, 71756, 71757, 71758, 71759, 71760, 71762, 71763, 71764, 71765, 71766, 71767, 71771, 71772, 71773, 71775, 71778, 71779, 71780, 71781, 71782, 71783, 71784, 71785, 71786, 71788, 71789, 71790, 71791, 71796, 71800, 71801, 71802, 71804, 71805, 71806, 71807, 71808, 71810, 71812, 71813, 71814, 71816, 71817, 71818, 71819, 71820, 71821, 71822, 71823, 71825, 71826, 71827, 71828, 71829, 71831, 71833, 71834, 71838, 71839, 71840, 71841, 71842, 71844, 71848, 71849, 71850, 71851, 71852, 71853, 71854, 71856, 71858, 71859, 71860, 71861, 71862, 71863, 71864, 71867, 71868, 71869, 71871, 71872, 71874, 71875, 71876, 71877, 71878, 71879, 71880, 71881, 71882, 71884, 71885, 71887, 71889, 71891, 71892, 71893, 71894, 71895, 71896, 71897, 71898, 71899, 71900, 71908, 71909, 71910, 71911, 71913, 71914, 71916, 71917, 71918, 71919, 71920, 71921, 71922, 71923, 71924, 71925, 71926, 71928, 71930, 71931, 71935, 71936, 71944, 71945, 71946, 71948, 71949, 71951, 71952, 71953, 71954, 71956, 71957, 71958, 71959, 71960, 71962, 71963, 71964, 71966, 71967, 71972, 71973, 71976, 71977, 71979, 71982, 71983, 71984, 71986, 71987, 71988, 71991, 71992, 71993, 71994, 71996, 71997, 71998, 71999, 85000, 85002, 85003, 85004, 85005, 85006, 85009, 85010, 85011, 85012, 85015, 85016, 85018, 85019, 85020, 85021, 85022, 85023, 85024, 85025, 85026, 85028, 85031, 85032, 85034, 85036, 85037, 85038, 85042, 85044, 85045, 85046, 85047, 85048, 85049, 85050, 85054, 85056, 85057, 85059, 85061, 85063, 85064, 85065, 85066, 85067, 85068, 85069, 85070, 85073, 85074, 85075, 85076, 85078, 85079, 85080, 85081, 85082, 85083, 85085, 85087, 85089, 85091, 85092, 85094, 85095, 85096, 85097, 85098, 85099, 85101, 85102, 85105, 85106, 85109, 85111, 85112, 85114, 85121, 85122, 85123, 85124, 85125, 85126, 85127, 85132, 85136, 85140, 85141, 85142, 85143, 85145, 85147, 85148, 85149, 85150, 85151, 85152, 85153, 85154, 85155, 85157, 85160, 85161, 85162, 85166, 85168, 85169, 85170, 85171, 85172, 85174, 85177, 85178, 85180, 85181, 85183, 85184, 85185, 85186, 85187, 85188, 85189, 85190, 85191, 85192, 85193, 85195, 85197, 85198, 85199, 85200, 85201, 85202, 85203, 85204, 85205, 85206, 85208, 85209, 85210, 85213, 85215, 85216, 85217, 85218, 85219, 85220, 85221, 85222, 85223, 85224, 85226, 85230, 85231, 85232, 85233, 85234, 85236, 85237, 85238, 85241, 85242, 85243, 85245, 85246, 85247, 85249, 85250, 85251, 85253, 85258, 85259, 85260, 85263, 85265, 85268, 85269, 85270, 85272, 85275, 85276, 85277, 85278, 85279, 85280, 85282, 85283, 85284, 85285, 85286, 85288, 85290, 85291, 85294, 85295, 85300, 85301, 85302, 85303, 85304, 85305, 85306, 85309, 85310, 85311, 85312, 85313, 85314, 85316, 85317, 85318, 85319, 85321, 85322, 85323, 85325, 85329, 85330, 85332, 85333, 85334, 85335, 85336, 85339, 85340, 85341, 85342, 85344, 85345, 85346, 85347, 85348, 85349, 85350, 85351, 85353, 85354, 85355, 85356, 85357, 85358, 85359, 85360, 85361, 85362, 85364, 85365, 85366, 85367, 85368, 85369, 85370, 85371, 85372, 85373, 85374, 85375, 85376, 85377, 85378, 85380, 85381, 85382, 85383, 85384, 85385, 85386, 85387, 85388, 85389, 85390, 85391, 85392, 85393, 85396, 85397, 85398, 85399, 85400, 85401, 85402, 85403, 85406, 85407, 85408, 85412, 85413, 85414, 85415, 85416, 85417, 85418, 85419, 85420, 85421, 85422, 85425, 85426, 85427, 85428, 85429, 85430, 85431, 85432, 85433, 85434, 85436, 85439, 85440, 85442, 85447, 85448, 85449, 85450, 85453, 85454, 85455, 85456, 85457, 85458, 85459, 85460, 85461, 85462, 85463, 85466, 85467, 85468, 85469, 85470, 85471, 85476, 85478, 85479, 85480, 85481, 85483, 85484, 85485, 85487, 85488, 85490, 85491, 85494, 85496, 85497, 85498, 85499, 85501, 85504, 85506, 85507, 85509, 85510, 85515, 85517, 85518, 85519, 85522, 85524, 85525, 85526, 85527, 85528, 85531, 85532, 85533, 85535, (2) 36, 38016, 42001, 42002, 42004, 42005, 42006, 42007, 42008, 42009, 42010, 42011, 42012, 42013, 42014, 42015, 42018, 42019, 42021, 42025, 42026, 42027, 42028, 42031, 42032, 42033, 42034, 42035, 42036, 42038, 42040, 42041, 42042, 42043, 42044, 42045, 42047, 42048, 42050, 42052, 42053, 42055, 42056, 42057, 42059, 42061, 42065, 42067, 42068, 42073, 42074, 42076, 42077, 42079, 42081, 42082, 42083, 42086, 42087, 42088, 42089, 42090, 42092, 42093, 42095, 42096, 42099, 42100, 42101, 42102, 42103, 42104, 42107, 42109, 42110, 42111, 42112, 42114, 42115, 42116, 42117, 42119, 42120, 42121, 42122, 42123, 42124, 42125, 42126, 42127, 42128, 42130, 42131, 42132, 42133, 42134, 42135, 42136, 42137, 42138, 42141, 42143, 42144, 42145, 42147, 42150, 42152, 42153, 42161, 42162, 42165, 42169, 42170, 42171, 42172, 42173, 42175, 42176, 42177, 42178, 42179, 42180, 42182, 42183, 42184, 42185, 42186, 42187, 42189, 42190, 42191, 42192, 42195, 42196, 42197, 42198, 42199, 42201, 42203, 42204, 42205, 42206, 42209, 42210, 42213, 42214, 42215, 42216, 42218, 42220, 42221, 42222, 42224, 42228, 42229, 42230, 42231, 42232, 42233, 42234, 42236, 42237, 42238, 42239, 42240, 42241, 42242, 42243, 42244, 42245, 42247, 42249, 42251, 42252, 42253, 42254, 42256, 42257, 42258, 42260, 42261, 42262, 42263, 42264, 42265, 42266, 42267, 42271, 42272, 42273, 42274, 42275, 42277, 42278, 42279, 42280, 42282, 42283, 42284, 42285, 42286, 42287, 42288, 42289, 42291, 42292, 42293, 42294, 42298, 42299, 42300, 42303, 42305, 42307, 42309, 42313, 42314, 42315, 42318, 42319, 42321, 42322, 42326, 42328, 42330, 42331, 42332, 42333, 42334, 42337, 42338, 42339, 42342, 42343, 42345, 42347, 42348, 42349, 42350, 42352, 42353, 42354, 42355, 42356, 42358, 42359, 42360, 42361, 42362, 42363, 42364, 42365, 42367, 42368, 42369, 42370, 42378, 42380, 42381, 42383, 42384, 42385, 42386, 42389, 42390, 42392, 42393, 42396, 42398, 42399, 42400, 42401, 42403, 42404, 42407, 42409, 42412, 42413, 42416, 42419, 42420, 42421, 42422, 42423, 42425, 42426, 42428, 42429, 42432, 42435, 42436, 42437, 42438, 42439, 42440, 42442, 42444, 42445, 42446, 42448, 42451, 42452, 42453, 42454, 42455, 42457, 42458, 42459, 42463, 42464, 42466, 42469, 42490, 42491, 42492, 42493, 42494, 42495, 42496, 42499, 42500, 42502, 42504, 42505, 42506, 42507, 42508, 42510, 42512, 42520, 42522, 42525, 42528, 42530, 42531, 42543, 42545, 42546, 42547, 42548, 42549, 42552, 42553, 42554, 42555, 42556, 42557, 42558, 42559, 42560, 42561, 42563, 42565, 42570, (3) 85600, 85601, 85604, 85606, 85607, 85608, 85611, 85612, 85613, 85614, 85615, 85616, 85617, 85619, 85620, 85622, 85625, 85626, 85628, 85629, 85630, 85631, 85633, 85636, 85637, 85638, 85641, 85642, 85646, 85650, 85652, 85653, 85654, 85656, 85657, 85658, 85659, 85660, 85662, 85664, 85666, 85667, 85672, 85673, 85674, 85679, 85681, 85686, 85692, 85693, 85696, 85700, 85703, 85704, 85706, 85707, 85710, 85715, 85718, 85719, 85720, 85721, 85722, 85723, 85724, 85725, 85727, 85729, 85730, 85732, 85735, 85738, 85739, 85740, 85743, 85745, 85749;

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.

device · product 8 of 19

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

Z-2207-2025

Recall number: Z-2207-2025
Initiated: June 30, 2025
Classification: Class II
Status: Ongoing
Recalling firm: Philips North America
Quantity: 350 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

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.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

Compare all device evidence states

Inspect official wording and provenance

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.

Code information

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, 78263, 78264, 78265, 78266, 78267, 78268, 78269, 78270, 78271, 78272, 78273, 78277, 78279, 78280, 78281, 78282, 78283, 78284, 78286, 78287, 78288, 78289, 78290, 78291, 78292, 78293, 78294, 78295, 78296, 78297, 78298, 78299, 78301, 78305, 78306, 78307, 78308, 78309, 78310, 78312, 78313, 78314, 78316, 78317, 78319, 78320, 78321, 78322, 78323, 78324, 78326, 78327, 78328, 78329, 78330, 78332, 78333, 78334, 78335, 78336, 78337, 78338, 78339, 78340, 78341, 78342, 78343, 78345, 78346, 78347, 78352, 78353, 78354, 78356, 78357, 78358, 78359, 78360, 78361, 78362, 78363, 78364, 78366, 78368, 78370, 78374, 78375, 78376, 78377, 78386, 2180210, (2) 78500, 78501, 78503, 78504, 78505, 78507, 78508, 78512, 78513, 78516, 78517, 78518, 78519, 78521, 78522, 78523, 78524, 78525, 78526, 78527, 78528, 78529, 78530, 78531, 78532, 78533, 78535, 78536, 78537, 78538, 78539, 78540, 78541, 78542, 78543, 78544, 78545, 78546, 78547, 78548, 78549, 78550, 78551, 78552, 78553, 78554, 78555, 78556, 78557, 78558, 78559, 78560, 78561, 78562, 78564, 78565, 78566, 78567, 78568, 78570, 78573;

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.

device · product 9 of 19

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

Z-2208-2025

Recall number: Z-2208-2025
Initiated: June 30, 2025
Classification: Class II
Status: Ongoing
Recalling firm: Philips North America
Quantity: 611 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

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.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

Compare all device evidence states

Inspect official wording and provenance

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.

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.

device · product 10 of 19

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

Z-2209-2025

Recall number: Z-2209-2025
Initiated: June 30, 2025
Classification: Class II
Status: Ongoing
Recalling firm: Philips North America
Quantity: 690 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

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.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

Compare all device evidence states

Inspect official wording and provenance

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.

Code information

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;

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.

device · product 11 of 19

Ingenia Elition S Model Numbers (REF): (1) 781357, (2) 782106, (3) 782137, (4) 782150 (China ONLY);

Z-2210-2025

Recall number: Z-2210-2025
Initiated: June 30, 2025
Classification: Class II
Status: Ongoing
Recalling firm: Philips North America
Quantity: 242 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

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.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

Compare all device evidence states

Inspect official wording and provenance

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.

Code information

Model Numbers (REF): (1) 781357, (2) 782106, (3) 782137, (4) 782150 (China ONLY); UDI-DI: (1) 00884838088108, (2) 00884838098329, (3) 00884838108615, (4) None; Serial Numbers: (1) 46001, 46002, 46003, 46004, 46005, 46007, 46008, 46011, 46012, 46013, 46014, 46015, 46016, 46017, 46018, 46019, 46020, 46021, 46023, 46024, 46025, 46026, 46027, 46029, 46030, 46031, 46032, 46033, 46036, 46037, 46039, 46041, 46042, 46044, 46045, 46046, 46048, 46049, 46050, 46052, 46053, 46054, 46055, 46057, 46058, 46059, 46060, 46061, 46065, 46066, 46067, 46068, 46069, 46071, 46075, 46076, 46077, 46078, 46081, 46082, 46083, 46085, 46086, 46088, 46089, 46092, 46093, 46094, 46095, 46097, 46101, 46104, 46107, 46109, 46111, 46119, 46121, (2) 46200, 46201, 46202, 46203, 46204, 46205, 46206, 46207, 46208, 46209, 46211, 46212, 46213, 46214, 46215, 46217, 46218, 46219, 46220, 46222, 46224, 46225, 46226, 46228, 46231, 46233, 46234, 46235, 46237, 46239, 46240, 46241, 46242, 46243, 46245, 46247, 46249, 46250, 46258, 46263, 46265, 46268, 46269, 46270, 46281, 46282, 46286, 46289, 46292, 46297, 46304, 46307, 46310, 46311, 46315, 46316, 46317, 46324, 46325, 46326, 46331, 46338, 46348, 46352, 46353, 46354, 46362, 46363, 46367, 46368, 46375, 46376, 46383, 46384, 46387, 46390, 46394, 61010, (3) 64001, 64002, 64003, 64004, 64005, 64007, 64008, 64009, 64011, 64013, 64014, 64015, 64016, 64019, 64022, 64023, 64024, 64028, 64029, 64030, 64032, 64034, 64039, 64045, 64046, (4) 26001, 26002, 26003, 26004, 26005, 26006, 26007, 26008, 26010, 26011, 26012, 26013, 26014, 26015, 26016, 26017, 26018, 26020, 26021, 26022, 26023, 26024, 26026, 26027, 26029, 26030, 26031, 26032, 26034, 26035, 26036, 26037, 26038, 26039, 26040, 26041, 26042, 26043, 26045, 26047, 26049, 26051, 26052, 26053, 26054, 26056, 26058, 26059, 26060, 26061, 26062, 26063, 26064, 26065, 26066, 26067, 26068, 26069, 26073, 26075, 26076, 26082;

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.

device · product 12 of 19

Ingenia Elition X Model Numbers (REF): (1) 781358, (2) 782107, (3) 782119, (4) 782136, (5) 782151 (China ONLY);

Z-2211-2025

Recall number: Z-2211-2025
Initiated: June 30, 2025
Classification: Class II
Status: Ongoing
Recalling firm: Philips North America
Quantity: 632 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

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.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

Compare all device evidence states

Inspect official wording and provenance

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.

Code information

Model Numbers (REF): (1) 781358, (2) 782107, (3) 782119, (4) 782136, (5) 782151 (China ONLY); UDI-DI: (1) 00884838088115, (2) 00884838098336, (3) 00884838104129, (4) 00884838108608, (5) None; Serial Numbers: (1) 42202, 45000, 45002, 45008, 45009, 45010, 45011, 45023, 45024, 45025, 45026, 45027, 45028, 45029, 45030, 45031, 45032, 45033, 45034, 45035, 45036, 45037, 45039, 45040, 45041, 45042, 45043, 45044, 45045, 45046, 45047, 45048, 45049, 45050, 45053, 45054, 45055, 45056, 45058, 45060, 45061, 45062, 45064, 45065, 45066, 45067, 45068, 45070, 45072, 45073, 45075, 45076, 45077, 45078, 45080, 45081, 45082, 45084, 45085, 45086, 45087, 45088, 45089, 45090, 45091, 45092, 45093, 45094, 45095, 45096, 45097, 45098, 45099, 45100, 45102, 45105, 45106, 45107, 45108, 45109, 45111, 45112, 45113, 45114, 45115, 45116, 45118, 45119, 45120, 45121, 45122, 45123, 45124, 45127, 45128, 45129, 45131, 45132, 45133, 45134, 45136, 45137, 45138, 45139, 45140, 45141, 45142, 45144, 45145, 45146, 45147, 45148, 45149, 45151, 45152, 45153, 45154, 45155, 45156, 45157, 45158, 45159, 45160, 45161, 45162, 45163, 45164, 45165, 45168, 45169, 45170, 45174, 45176, 45177, 45178, 45180, 45181, 45183, 45184, 45185, 45186, 45187, 45188, 45189, 45190, 45191, 45192, 45193, 45194, 45195, 45197, 45203, 45204, 45205, 45207, 45210, 45211, 45212, 45215, 45216, 45217, 45218, 45219, 45220, 45222, 45224, 45227, 45228, 45229, 45231, 45235, 45237, 45238, 45241, 45242, 45243, 45244, 45245, 45246, 45247, 45248, 45249, 45250, 45252, 45253, 45257, 45259, 45260, 45261, 45262, 45264, 45265, 45267, 45268, 45269, 45272, 45274, 45276, 45277, 45278, 45279, 45280, 45281, 45282, 45284, 45289, 45290, 45292, 45293, 45294, 45295, 45296, 45300, 45302, 45311, 45312, 45313, 45314, 45315, 45316, 45317, 45319, 45320, 45321, 45322, 45323, 45328, 45330, 45332, 45333, 45335, 45337, 45338, 45339, 45340, 45342, 45343, 45344, 45345, 45348, 45349, 45350, 45352, 45353, 45354, 45355, 45356, 45357, 45359, 45360, 45362, 45363, 45364, 45367, 45368, 45369, 45370, 45371, 45372, 45374, 45376, 45377, 45378, 45379, 45381, 45382, 45390, 45391, 45392, 45393, 45394, 45395, 45396, 45397, 45398, 45399, 45406, 45407, 45408, 45409, 45410, 45411, 45412, 45414, 45416, 45417, 45419, 45421, 45423, 45426, 45428, 45429, 45432, 45434, 45435, 45437, 45438, 45439, 45441, 45442, 45443, 45444, 45446, 45447, 45448, 45450, 45451, 45456, 45459, 45461, 45463, 45467, 45469, 45470, 45471, 45473, 45474, 45476, 45480, (2) 45500, 45501, 45503, 45504, 45506, 45507, 45508, 45509, 45510, 45511, 45514, 45516, 45517, 45518, 45519, 45520, 45521, 45523, 45524, 45525, 45528, 45529, 45530, 45531, 45532, 45533, 45534, 45536, 45538, 45540, 45542, 45543, 45544, 45545, 45546, 45547, 45550, 45551, 45554, 45556, 45559, 45560, 45561, 45562, 45563, 45564, 45565, 45566, 45567, 45568, 45570, 45572, 45573, 45574, 45577, 45578, 45579, 45580, 45583, 45587, 45589, 45590, 45594, 45595, 45596, 45599, 45600, 62011, 62012, 62016, 62017, 62018, 62019, 62021, 62023, 62024, 62026, 62029, 62030, 62031, 62033, 62035, 62038, 62039, 62040, 62041, 62042, 62044, 62046, 62047, 62048, 62050, 62051, 62052, 62054, 62056, 62058, 62059, 62061, 62062, 62063, 62065, 62066, 62067, 62070, 62071, 62073, 62080, 62081, 62082, 62083, 62084, 62087, 62088, 62090, 62091, 62092, 62097, 62098, 62100, 62103, 62104, 62106, 62107, 62108, 62109, 62110, 62111, 62112, 62113, 62114, 62115, 62117, 62118, 62119, 62120, 62122, 62124, 62125, 62126, 62127, 62128, 62129, 62130, 62132, 62133, 62134, 62136, 62137, 62138, 62139, 62140, 62142, 62145, 62146, 62147, 62148, 62151, 62152, 62153, 62154, 62155, 62156, 62157, 62158, 62159, 62162, 62163, 62164, 62166, 62167, 62168, 62170, 62173, 62176, 62178, 62179, 62180, 62181, 62182, 62183, 62184, 62186, 62187, 62188, 62189, 62190, 62191, 62196, 62197, 62198, 62199, 62200, 62201, 62202, 62203, 62204, 62205, 62206, 62207, 62208, 62209, 62210, 62211, 62212, 62213, 62214, 62215, 62216, 62217, 62218, 62219, 62223, 62224, 62225, 62226, 62227, 62228, 62230, 62231, 62232, 62241, 62243, (3) 66001, 66002, (4) 28500, 28502, 28503, 28504, 28506, 28507, 28509, 28510, 28514, 28515, 28516, 28517, 28518, 28520, 28521, 28523, 28524, 28525, 28526, 28527, 28528, 28529, 28531, 28532, 28533, 28535, 28536, 28537, 28538, 28539, 28540, 28542, 28543, 28545, 28546, 28547, 28548, 28550, 28552, 28554, 28555, 28558, 28559, 28560, 28561, 28563, 28564, 28565, 28566, 28567, 28568, 28569, 28572, 28575, 28576, 28581, 28587, 28592, (5) 26500, 26501, 26503, 26504, 26505, 26506, 26507, 26508, 26509, 26510, 26511, 26512, 26513, 26514, 26515, 26517, 26518, 26519, 26520, 26521, 26524, 26525, 26526, 26527, 26528, 26529, 26530, 26531, 26532, 26535;

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.

device · product 13 of 19

Intera 3.0T Quasar Dual Model Number (REF): 781150;

Z-2212-2025

Recall number: Z-2212-2025
Initiated: June 30, 2025
Classification: Class II
Status: Ongoing
Recalling firm: Philips North America
Quantity: 1 unit

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

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.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

Compare all device evidence states

Inspect official wording and provenance

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.

Code information

Model Number (REF): 781150; UDI-DI: None Serial Numbers: 17123

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.

device · product 14 of 19

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

Z-2213-2025

Recall number: Z-2213-2025
Initiated: June 30, 2025
Classification: Class II
Status: Ongoing
Recalling firm: Philips North America
Quantity: 551 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

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.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

Compare all device evidence states

Inspect official wording and provenance

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.

Code information

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, 63267, 63268, 63269, 63270, 63271, 63272, 63273, 63274, 63275, 63276, 63277, 63281, 63282, 63283, 63284, 63285, 63286, 63287, 63288, 63289, 63290, 63292, 63294, 63295, 63296, 63297, 63299, 63300, 63301, 63302, 63303, 63304, 63305, 63306, 63307, 63308, 63309, 63311, 63312, 63313, 63314, 63315, 63316, 63318, 63319, 63322, 63323, 63325, 63328, 63330, 63331, 63333, 63334, 63336, 63337, 63340, 63343, 63344, 63346, 63352, 63355, 63356, 63357, 63360, 63361, 63363, 63364, 63365, 63366, 63367, 63369, 63370, 63371, 63372, 63374, 63375, 63379, 63380, 63383, 63384, 63385, 63386, 63388, 63389, 63393, 63394, 63396, 63397, 63398, 63400, 63401, 63402, 63408, 63409, 63410, 63411, 63412, 63413, 63416, 63418, 63419, 63422, 63424, 63425, 63428, 63429, 63430, 63431, 63432, 63433, 63434, 63435, 63437, 63438, 63439, 63440, 63442, 63443, 63445, 63446, 63449, 63451, 63452, 63453, 63455, 63456, 63457, 63461, 63464, 63466, 63474, 63475, 63477, 63478, 63482, 63484, 63487, 63488, 63489, 63492, 63493, 63494, 63497, 63498, 63499, 63500, 63502, 63503, 63504, 63506, 63507, 63510, 63513, 63514, 63515, 63519, 63520, 63521, 63522, 63523, 63524, 63530, 63531, 63532, 63533, 63534, 63541, 63547, 63548, 63550, 63555, 63557, 63559, 63560, 63561, 63562, 63563, 63564, 63565, 63566, 63567, 63569, 63570, 63571, 63572, 63576, 63583, 63586, 63587, 63589, 63593, 63596, 63597, 63598, 63599, 63603, 63604, 63609, 63610, 63612, 63614, 63615, 63616, 63618, 63623, 63624, 63626, 63630, 63631, 63632, 63633, 63639, 63650, 63664, 63665, 63666, 63668, 63672, 63673, 63674, 63679, 63684, 63694, 63696, 63697, 63698, 63699, 63704, (2) 28001, 28002, 28003, 28004, 28006, 28008, 28009, 28010, 28011, 28012, 28013, 28014, 28015, 28017, 28021, (3) 69000, 69003, 69004, 69005, 69006, 69007, 69008, 69010, 69011, 69012, 69014, 69015, 69016, 69017, 69019, 69020, 69021, 69022, 69023, 69024, 69026, 69027, 69029, 69030, 69031, 69032, 69034, 69036, 69037, 69041, 69043, 69044, 69045, 69046, 69048, 69051, 69052, 69053, 69055, 69056, 69058, 69060, 69061, 69063, 69064, 69065, 69066, 69067, 69068, 69069, 69070, 69071, 69072, 69073, 69075, 69076, 69077, 69078, 69080, 69081, 69082, 69085, 69086, 69087, 69089, 69092, 69093, 69094, 69095, 69096, 69097, 69098, 69099, 69100, 69102, 69103, 69106, 69107, 69110, 69111, 69112, 69115, 69116, 69121, 69122, 69123, 69124, 69126, 69127, 69128, 69130, 69131, 69133, 69136, 69137, 69141, 69142, 69145, 69147, 69150, 69154, 69161, 69169, 69170, 69171, 69172, 69175, 69176, 69178, 69179, 69195, 69216, 69233;

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.

device · product 15 of 19

MR 7700 Model Numbers (REF): (1) 782120, (2) 782153;

Z-2214-2025

Recall number: Z-2214-2025
Initiated: June 30, 2025
Classification: Class II
Status: Ongoing
Recalling firm: Philips North America
Quantity: 82 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

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.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

Compare all device evidence states

Inspect official wording and provenance

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.

Code information

Model Numbers (REF): (1) 782120, (2) 782153; UDI-DI: (1) 00884838104112, (2) 00884838112858; Serial Numbers: (1) 65000, 65001, 65002, 65003, 65004, 65005, 65006, 65007, 65008, 65009, 65011, 65012, 65013, 65014, 65015, 65016, 65017, 65018, 65019, 65020, 65021, 65023, 65024, 65025, 65026, 65027, 65028, 65029, 65030, 65031, 65032, 65034, 65035, 65037, 65038, 65039, 65040, 65041, 65042, 65043, 65049, 65050, 65051, 65056, 65057, 65059, 65060, 65061, 65063, 65064, 65065, 65066, 65067, (2) 68000, 68001, 68006, 68007, 68008, 68009, 68010, 68011, 68012, 68013, 68014, 68015, 68016, 68017, 68018, 68020, 68022, 68023, 68024, 68025, 68028, 68029, 68030, 68031, 68033, 68034, 68036, 68037, 68041;

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.

device · product 16 of 19

SmartPath to dStream for 3.0T Model Number (REF): 782145;

Z-2215-2025

Recall number: Z-2215-2025
Initiated: June 30, 2025
Classification: Class II
Status: Ongoing
Recalling firm: Philips North America
Quantity: 15 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

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.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

Compare all device evidence states

Inspect official wording and provenance

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.

Code information

Model Number (REF): 782145; UDI-DI: 00884838108684; Serial Numbers: 17377, 17385, 17435, 34114, 34208, 38118, 38127, 38170, 38294, 38313, 38336, 73002, 73004, 74002, 74004;

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.

device · product 17 of 19

SmartPath to dStream for XR and 3.0T Model Numbers (REF): (1) 781270, (2) 782113, (3) 782129;

Z-2216-2025

Recall number: Z-2216-2025
Initiated: June 30, 2025
Classification: Class II
Status: Ongoing
Recalling firm: Philips North America
Quantity: 294 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

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.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

Compare all device evidence states

Inspect official wording and provenance

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.

Code information

Model Numbers (REF): (1) 781270, (2) 782113, (3) 782129; UDI-DI: (1) 00884838095083, (2) 00884838098909, (3) 00884838105805; Serial Numbers: (1) 17006, 17172, 17204, 17206, 17212, 17215, 17222, 17237, 17239, 17240, 17242, 17245, 17246, 17247, 17250, 17260, 17264, 17265, 17266, 17268, 17269, 17274, 17283, 17284, 17286, 17290, 17292, 17299, 17302, 17308, 17309, 17313, 17321, 17326, 17339, 17342, 17344, 17352, 17353, 17356, 17357, 17360, 17366, 17367, 17369, 17375, 17378, 17386, 17388, 17389, 17398, 17399, 17406, 17415, 17416, 17425, 17428, 17429, 17434, 17436, 17440, 17447, 17459, 17464, 17466, 17468, 17473, 17490, 17491, 17493, 17495, 17499, 17508, 17509, 17514, 17516, 17517, 17524, 17533, 17536, 17544, 17546, 17550, 17556, 17559, 17564, 17565, 17569, 17570, 17572, 17580, 17589, 17590, 17594, 17615, 23002, 23026, 23030, 23033, 23034, 23036, 24006, 24012, 24013, 24018, 24020, 24022, 24023, 24025, 24036, 24047, 24055, 24058, 24075, 24076, 24087, 24090, 24095, 24098, 24108, 24109, 24110, 24111, 24117, 24124, 24133, 24134, 24143, 24145, 34032, 34036, 34037, 34058, 34060, 34067, 34076, 34080, 34083, 34090, 34096, 34107, 34111, 34142, 34145, 34152, 34154, 34211, 34221, 34223, 34233, 34236, 34246, 34249, 34250, 34261, 34292, 35027, 35031, 35032, 35040, 35043, 35044, 35046, 35047, 35048, 35052, 35053, 35056, 35060, 35073, 35078, 35087, 38001, 38004, 38005, 38006, 38013, 38015, 38020, 38023, 38026, 38032, 38037, 38038, 38040, 38041, 38062, 38063, 38065, 38071, 38076, 38084, 38089, 38102, 38109, 38111, 38113, 38116, 38120, 38126, 38131, 38134, 38135, 38138, 38161, 38168, 38184, 38192, 38198, 38199, 38202, 38214, 38217, 38224, 38225, 38235, 38259, 38263, 38300, 38317, 38356, 38366, 74011, (2) 17238, 17252, 17258, 17271, 17307, 17346, 17372, 17376, 17439, 17449, 17455, 17461, 17470, 17504, 17521, 17560, 24021, 24039, 24052, 24077, 24093, 24146, 34056, 34059, 34072, 34110, 34117, 34127, 34128, 34129, 34130, 34131, 34143, 34153, 34172, 34202, 34212, 34262, 34304, 35041, 35045, 35059, 35071, 38010, 38011, 38042, 38049, 38066, 38070, 38075, 38082, 38094, 38105, 38106, 38117, 38142, 38166, 38197, 38219, 38222, 38230, 38234, 38281, 38290, 38310, 38311, 38354, 74036, 74040, (3) 34055, 38195;

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.

device · product 18 of 19

SmartPath to Ingenia Elition X Model Numbers (REF): (1) 782118, (2) 782144;

Z-2217-2025

Recall number: Z-2217-2025
Initiated: June 30, 2025
Classification: Class II
Status: Ongoing
Recalling firm: Philips North America
Quantity: 33 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

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.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

Compare all device evidence states

Inspect official wording and provenance

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.

Code information

Model Numbers (REF): (1) 782118, (2) 782144; UDI-DI: (1) 00884838099746, (2) 00884838108677; Serial Numbers: (1) 42049, 42054, 42072, 42085, 42098, 42113, 42158, 42159, 42160, 42167, 42194, 42301, 42306, 42329, 42340, 71019, 71025, 71050, 71528, 85655, 85661, 85665, 85676, (2) 42062, 42105, 42250, 42323, 42346, 42441, 71278, 71366, 71504, 71508;

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.

device · product 19 of 19

Upgrade to MR 7700 Model Number (REF): 782130;

Z-2218-2025

Recall number: Z-2218-2025
Initiated: June 30, 2025
Classification: Class II
Status: Ongoing
Recalling firm: Philips North America
Quantity: 26 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

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.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

Compare all device evidence states

Inspect official wording and provenance

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.

Code information

Model Number (REF): 782130; UDI-DI: 00884838104402; Serial Numbers: 42030, 42037, 42066, 42151, 42163, 42164, 42211, 42219, 42248, 42376, 45001, 45007, 45051, 45052, 45179, 45236, 45297, 45298, 45301, 45552, 45555, 71613, 71907, 85394, 85643, 85644;

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.

Event summary

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Every recalled product in this event

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