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

Summary

The FDA issued a Class II for Ingenia 1.5T Model Numbers (REF): (1) 781315, (2) 718641, (3) 781396, (4) 78210 by Philips North America. Reason: The potential for component failures in the Gradient Coil of the affected MR systems may act as a heat source with a potential to produce smoke and/or.

Details

Product Description

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

Lot/Code Info: 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, 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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, 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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;

Quantity Affected: 2,279 units

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.

Type: Voluntary: Firm initiated

Recall Initiated: 2025-06-30

Company