Official recall notice

FDA DeviceClass IINotable

MR 5300 Recall (Sep 2026) – Philips

Product: MR 5300 Model Number (REF): 1. 782110, 2. 782152;

Recall date
2026-09-30
FDA class
Class II

Why it was recalled

Hazard

A software issue will terminate an examination during the image reconstruction process if the scan parameters are manually adjusted such that reconstruction requirements exceed the available system memory.

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Product description

A software issue will terminate an examination during the image reconstruction process if the scan parameters are manually adjusted such that reconstruction requirements exceed the available system memory.

Affected products

1. Model Number (REF): 782110; UDI-DI: 884838099364; Serial Numbers: 63383, 63384, 63385, 63386, 63422, 63435, 63643, 63346, 63021, 63054, 63091, 63092, 63113, 63313, 63314, 63315, 63322, 63521, 63524, 63565, 63572, 63593, 63604, 63639, 63694, 63697, 63705, 63706, 63707, 63716, 63721, 63727, 63736, 63737, 63739, 63743, 63750, 63753, 63754, 63755, 63769, 63773, 63617, 63560, 63038, 63484, 63023, 63064, 63066, 63075, 63086, 63149, 63161, 63183, 63194, 63195, 63198, 63199, 63308, 63319, 63331, 63334, 63336, 63364, 63371, 63412, 63425, 63429, 63430, 63452, 63515, 63525, 63609, 63615, 63633, 63636, 63638, 63666, 63668, 63675, 63687, 63689, 63690, 63695, 63696, 63729, 63730, 63742, 63763, 63765, 63774, 63787, 63806, 63829, 63686, 63193, 63257, 63431, 63583, 63592, 63123, 63155, 63474, 63576, 63416, 63748, 63337, 63456, 63046, 63157, 63357, 63569, 63000, 63325, 63504, 63506, 63104, 63110, 63115, 63186, 63248, 63250, 63252, 63343, 63344, 63586, 63785, 63820, 63821, 63328, 63664, 63771, 63457, 63070, 63356, 63011, 63013, 63022, 63028, 63083, 63095, 63107, 63202, 63292, 63365, 63432, 63490, 63499, 63500, 63594, 63031, 63217, 63219, 63220, 63221, 63271, 63309, 63025, 63125, 63211, 63451, 63508, 63541, 63559, 63623, 63745, 63019, 63034, 63058, 63084, 63168, 63218, 63374, 63443, 63510, 63057, 63063, 63493, 63513, 63564, 63612, 63684, 63719, 63812, 63366, 63372, 63026, 63074, 63093, 63099, 63109, 63111, 63112, 63130, 63169, 63175, 63176, 63177, 63178, 63188, 63210, 63223, 63224, 63228, 63229, 63240, 63312, 63333, 63341, 63342, 63389, 63408, 63413, 63428, 63466, 63483, 63487, 63523, 63531, 63532, 63533, 63557, 63566, 63567, 63571, 63596, 63598, 63602, 63614, 63618, 63619, 63632, 63650, 63665, 63672, 63673, 63677, 63732, 63749, 63035, 63041, 63043, 63047, 63062, 63090, 63100, 63128, 63136, 63140, 63141, 63150, 63152, 63160, 63162, 63172, 63173, 63182, 63222, 63238, 63244, 63253, 63258, 63363, 63367, 63370, 63393, 63394, 63126, 63323, 63558, 63080, 63699, 63514, 63388, 63410, 63411, 63723, 63311, 63375, 63507, 63159, 63396, 63122, 63068, 63433, 63001, 63784, 63679, 63409, 63756, 63762, 63434, 63259, 63379, 63277, 63301, 63187, 63464, 63758, 63759, 63098, 63134, 63326, 63355, 63418, 63561, 63562, 63624, 63032, 63036, 63069, 63139, 63437, 63438, 63439, 63610, 63700, 63708, 63709, 63710, 63733, 63738, 63746, 63786, 63103, 63164, 63534, 63563, 63589, 63631, 63127, 63603, 63720, 63482, 63489, 63494, 63498, 63547, 63555, 63106, 63108, 63402, 63475, 63698, 63775, 63776, 63822, 63825, 63273, 63424, 63626, 63397, 63398, 63445, 63006, 63008, 63009, 63015, 63016, 63024, 63030, 63042, 63044, 63049, 63053, 63105, 63135, 63138, 63151, 63153, 63154, 63492, 63352, 63059, 63497, 63681, 63488, 63503, 63722, 63071, 63072, 63294, 63295, 63296, 63297, 63299, 63340, 63361, 63455, 63519, 63724, 63770, 63067, 63174, 63191, 63197, 63449, 63674, 63800, 63798, 63039, 63165, 63318, 63330, 63380, 63440, 63012, 63014, 63018, 63029, 63033, 63087, 63196, 63203, 63204, 63316, 63520, 63587, 63477, 63530, 63740, 63201, 63400, 63401, 63446, 63453, 63478, 63502, 63550, 63597, 63605, 63616, 63704, 63747, 63757, 63780, 63823, 63824, 63833, 63119, 63442, 63461, 63570, 63766, 63767, 63810; 2. Model Number (REF): 782152; UDI-DI: N/A; Serial Numbers: 69304, 69349, 69098, 69101, 69250, 69318, 69321, 69338, 69238, 69239, 69024, 69026, 69034, 69039, 69046, 69081, 69083, 69105, 69151, 69235, 69023, 69037, 69041, 69066, 69112, 69152, 69233, 69302, 69299, 69193, 69194, 69241, 69287, 69320, 69070, 69071, 69106, 69110, 69127, 69161, 69360, 69366, 69044, 69045, 69048, 69116, 69286, 69300, 69351, 69055, 69073, 69075, 69086, 69191, 69207, 69243, 69252, 69258, 69260, 69261, 69262, 69264, 69268, 69270, 69288, 69290, 69295, 69296, 69297, 69000, 69003, 69008, 69010, 69011, 69014, 69015, 69017, 69030, 69147, 69312, 69325, 69326, 69327, 69328, 69329, 69330, 69331, 69332, 69333, 69334, 69289, 69340, 69115, 69200, 69201, 69263, 69154, 69342, 69348, 69170, 69135, 69139, 69197, 69271, 69277, 69133, 69185, 69215, 69234, 69038, 69189, 69053, 69058, 69065, 69078, 69085, 69092, 69103, 69122, 69123, 69169, 69177, 69179, 69216, 69220, 69221, 69224, 69225, 69228, 69229, 69267, 69301, 69305, 69306, 69307, 69313, 69314, 69323, 69343, 69365, 69316, 69027, 69096, 69097, 69186, 69212, 69240, 69254, 69255, 69063, 69064, 69069, 69080, 69095, 69126, 69176, 69315, 69005, 69067, 69175, 69198, 69247, 69294, 69298, 69336;

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