CLASS II ONGOING Device recall · Reported 30 Sep 2026 · FDA Enforcement Report

MR 5300 Model Number (REF): 1. recalled by Philips North America

Philips North America is recalling MR 5300 Model Number (REF): 1. 782110, 2. 782152, distributed nationwide in the US. The recall was initiated on 21 Aug 2026 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codes1. 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;

Quantity recalled611

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-3241-2026
FDA event ID: 99769
Recalling firm: Philips North America, Cambridge, MA
Classification: Class II
Status: Ongoing
Recall initiated: 21 Aug 2026
FDA classified: 18 Sep 2026
Reported: 30 Sep 2026
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Device Malfunction
Device type: Other Medical Devices

Timeline

21 Aug 2026	Recall initiated by company
18 Sep 2026	Classified by FDA	+28 days
30 Sep 2026	Published in enforcement report	+12 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

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.

Device recalls are issued when a component, software or design fault could cause the device to fail or give wrong readings. Many are corrections applied in the field rather than physical returns.

Product as listed by the FDA

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

Where it was distributed

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;

Nationwide Georgia

Questions about this recall

Why was it recalled?

Which lots are affected?

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;

Where was it sold?

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 6 Oct 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

Other products in this recall event

11 other products · FDA event 99769

This product is part of a recall event; the main page for the event is Achieva 3.0T recalled by Philips North America.

Reported	Class	Recall	Company	Reason	Where
30 Sep 2026	CLASS II	Achieva 3.0T recalled by Philips North America	Philips North America	Device Malfunction	Nationwide
30 Sep 2026	CLASS II	Ingenia Elition S and Ingenia Elition recalled by Philips North America	Philips North America	Device Malfunction	Nationwide
30 Sep 2026	CLASS II	MR 7700 and Upgrade to MR recalled by Philips North America	Philips North America	Device Malfunction	Nationwide
30 Sep 2026	CLASS II	Ingenia 1.5T, Ingenia 1.5T CX and Ingenia 1.5T recalled	Philips North America	Device Malfunction	Nationwide
30 Sep 2026	CLASS II	Achieva XR recalled by Philips North America	Philips North America	Device Malfunction	Nationwide
30 Sep 2026	CLASS II	Evolution upgrade 1.5T and Evolution upgrade 3.0T recalled	Philips North America	Device Malfunction	Nationwide
30 Sep 2026	CLASS II	Ingenia 3.0T and Ingenia 3.0T CX recalled by Philips North America	Philips North America	Device Malfunction	Nationwide
30 Sep 2026	CLASS II	Name (Model Number): 1. Intera 1.5T (781195), 2. Intera 1.5T recalled	Philips North America	Device Malfunction	Nationwide
30 Sep 2026	CLASS II	Ingenia Ambition S and Ingenia Ambition recalled	Philips North America	Device Malfunction	Nationwide
30 Sep 2026	CLASS II	Achieva 1.5T, Achieva 1.5T Conversion recalled by Philips North America	Philips North America	Device Malfunction	Nationwide
30 Sep 2026	CLASS II	SmartPath to dStream for XR and 3.0T recalled by Philips North America	Philips North America	Device Malfunction	Nationwide

More recalls from Philips North America

All 545

Reported	Class	Recall	Company	Reason	Where
30 Sep 2026Device	CLASS II	SmartPath to dStream for XR and 3.0T recalled by Philips North America	Philips North America	Device Malfunction	Nationwide
30 Sep 2026Device	CLASS II	Achieva 1.5T, Achieva 1.5T Conversion recalled by Philips North America	Philips North America	Device Malfunction	Nationwide
30 Sep 2026Device	CLASS II	Ingenia Ambition S and Ingenia Ambition recalled	Philips North America	Device Malfunction	Nationwide
30 Sep 2026Device	CLASS II	Name (Model Number): 1. Intera 1.5T (781195), 2. Intera 1.5T recalled	Philips North America	Device Malfunction	Nationwide
30 Sep 2026Device	CLASS II	Ingenia 3.0T and Ingenia 3.0T CX recalled by Philips North America	Philips North America	Device Malfunction	Nationwide

Other Other Medical Devices recalls

All 13,857

Reported	Class	Recall	Company	Reason	Where
30 Sep 2026Device	CLASS II	Medline Convenience Kits: Major Pack recalled by Medline Industries	Medline Industries	Other	Nationwide
30 Sep 2026Device	CLASS II	Medline Convenience Kits: Peds Sinus Pack recalled by Medline Industries	Medline Industries	Other	Nationwide
30 Sep 2026Device	CLASS II	SmartPath to dStream for XR and 3.0T recalled by Philips North America	Philips North America	Device Malfunction	Nationwide
30 Sep 2026Device	CLASS II	Achieva 1.5T, Achieva 1.5T Conversion recalled by Philips North America	Philips North America	Device Malfunction	Nationwide
30 Sep 2026Device	CLASS II	Medline Convenience Kits: Mfc Craniotomy Pack recalled	Medline Industries	Other	Nationwide