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FDAFDA · Food and drugs·Recall number Z-2206-2025

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

Published August 6, 2025 · Recall initiated: June 30, 2025

Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.

What's the hazard

The potential for component failures in the Gradient Coil of the affected MR systems may act as a heat source with a potential to produce smoke and/or fire.

What to do

Voluntary: Firm initiated · Letter

Recall details

Manufacturer
Philips North America
Distributor
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.
Lot
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
Risk classification
Class II
Area (FDA)
device
Country
United States

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