⚠ RecallRadar📷 ScanGuidesOfficial U.S. recall notices, restated plainly

Philips North America Llc: MR 5300 Model Number (REF): 1. 782110, 2. 782152;

Medical DevicesSource: FDA (device) · Date: 2026-09-30

Read the official notice at FDA (device) →

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The text below is copied from the official FDA (device) record. If anything differs, the official notice is correct.

Company / brand
Philips North America Llc
Product
MR 5300 Model Number (REF): 1. 782110, 2. 782152;
Reason / 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.
Classification
Class II
Status
Ongoing
Distribution / sold at
Worldwide distribution - US Nationwide and the countries of Albania, Algeria, Andorra, Angola, Argentina, Australia, Austria, Bahamas, Bahrain, Bangladesh, Belarus, Belgium, Belize, Bolivia, Bosnia and Herzegovina, Brazil, Bulgaria, Canada, Cayman Islands, Chile, China, Colombia, Costa Rica, C¿te D'Ivoire, Croatia, Cuba, Cyprus, Czech Republic, Denmark, Dominican Republic, Ecuador, Egypt, El Salvador, Equatorial Guinea, Estonia, Fiji, Finland, France, French Polynesia, Georgia, Germany, Ghana, Greece, Guadeloupe, Guernsey, Honduras, Hong Kong, Hungary, India, Indonesia, Iran, Iraq, Ireland, Israel, Italy, Japan, Jersey, Jordan, Kazakhstan, Kenya, Korea, Republic of, Kuwait, Kyrgyzstan, Lao People's Democratic Republic, Latvia, Lebanon, Libya, Lithuania, Luxembourg, Macao, Macedonia, Madagascar, Malaysia, Maldives, Malta, Martinique, Mauritius, Mayotte, Mexico, Moldova, Monaco, Mongolia, Montenegro, Morocco, Myanmar, Nepal, Netherlands, New Zealand, Nicaragua, Nigeria, Norway, Oman, Pakistan, Palestine, State of, Panama, Papua New Guinea, Paraguay, Peru, Philippines, Poland, Portugal, Qatar, R¿union, Romania, Russian Federation, Saudi Arabia, Serbia, Singapore, Slovakia, Slovenia, South Africa, Spain, Sri Lanka, Sweden, Switzerland, Syrian Arab Republic, Taiwan, Tanzania, Thailand, Trinidad and Tobago, Tunisia, Turkey, Turkmenistan, Ukraine, United Arab Emirates, United Kingdom, Uzbekistan, Venezuela, Viet Nam, Yemen, Zambia;
Recall initiated
2026-08-21
Code info
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;
Product quantity
611
Voluntary mandated
Voluntary: Firm initiated
City
Cambridge
State
MA
Country
United States
Event id
99769
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