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Recall data is sourced from official U.S. government agencies (CPSC, FDA, NHTSA, USDA) and processed using AI to improve readability. This site is not affiliated with or endorsed by any government agency. Always refer to the original agency notice for authoritative information.

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Medium RiskFDA Device
Medical Devices/Diagnostic Equipment

Philips North America Llc: Magnetic Resonance Systems Recalled for Incorrect Support Table Installation

Agency Publication Date: April 17, 2024
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Summary

Approximately 10,221 Philips North America Magnetic Resonance (MR) Systems have been recalled because the floor plate for the patient support table may have been installed incorrectly. This defect can lead to stability issues with the table used to hold patients during imaging procedures. Affected models include various versions of the Achieva, Ingenia, Intera, MR 5300, and MR 7700 systems sold worldwide. Customers should contact the manufacturer or their healthcare provider for guidance regarding equipment inspections and safety measures.

Risk

An incorrectly installed floor plate can cause the patient support table to shift or become unstable during use. This instability poses a risk of physical injury to patients while they are being positioned or scanned within the MRI machine.

What You Should Do

  1. Identify your specific medical device by checking the model and serial numbers against the extensive list of affected Achieva, GYROSCAN, Ingenia, Intera, and MR series systems.
  2. Verify if your system was upgraded via 'SmartPath to dStream' for 1.5T, XR, or 3.0T systems, as these upgrades are also included in the recall.
  3. If your facility operates an affected unit, contact Philips North America Llc at 222 Jacobs St, Cambridge, Massachusetts, 02141-2289 for technical support and to schedule an inspection of the floor plate installation.
  4. Contact your healthcare provider or the manufacturer for further instructions and information on corrective actions or potential remedies.
  5. For additional questions or to report incidents, contact the FDA at 1-888-463-6332 or visit the medical device recall section at www.fda.gov.

Your Remedy Options

๐Ÿ“‹Other Action

Manufacturer correction/inspection

How to: Contact your healthcare provider or the manufacturer for further instructions and information on system inspections and potential remedy actions.

Affected Products

Product: Achieva 1.5T, Magnetic Resonance System
Model / REF:
781196
781296
781343
Lot Numbers:
Serial No. 32508, 21935, 32084, 22167, 21313, 21681, 32550, 32717, 32083, 22136, 22319, 32095, 32481, 22001, 21237, 21968, 32474, 32500, 21715, 22245, 21693, 21798, 21572, 22025, 32966, 21045, 22140, 21183, 21962, 32034, 21428, 21192, 21957, 21176, 32171, 22215, 21232, 32085, 22207, 22004, 22066, 21666, 21851, 32390, 21104, 21574, 21272, 21111, 32381, 21598, 21351, 21432, 21965, 21178, 21812, 21805, 21688, 21073, 21120, 21117, 21128, 21085, 21086, 21185, 21162, 21125, 21250, 21153, 21144, 21243, 21235, 21315, 21360, 21265, 21559, 21263, 21244, 21160, 21317, 21342, 21312, 21165, 21274, 21215, 21416, 21136, 21382, 21443, 21454, 21329, 21348, 21226, 21344, 21225, 21297, 21460, 21414, 21281, 21530, 21306, 21444, 21459, 21413, 21430, 21457, 21449, 21052, 21592, 21427, 21431, 21238, 21489, 21488, 21570, 21896, 21625, 21465, 21401, 21578, 21398, 21518, 21295, 21013, 21397, 21134, 21503, 21509, 21624, 21463, 21658, 21588, 21585, 21646, 21647, 21689, 21627, 21711, 21696, 21412, 21699, 21548, 21378, 21654, 21698, 21492, 21707, 21338, 21708, 21690, 21677, 21782, 21787, 21729, 21738, 21731, 21760, 21686, 21914, 22047, 21903, 21750, 21724, 21911, 21794, 21808, 21875, 21876, 21877, 21730, 21815, 21951, 21900, 21100, 21186, 21593, 21655, 21704, 21747, 21751, 21795, 21802, 21984, 21950, 21961, 21919, 21757, 22019, 22233, 21989, 22039, 22032, 22050, 21955, 22037, 22046, 21985, 22002, 22054, 22065, 22028, 22033, 22000, 22062, 21943, 22108, 22038, 21790, 22058, 22068, 21920, 21983, 22006, 22022, 22082, 22078, 22072, 22075, 22076, 22024, 22080, 22023, 22079, 22090, 22016, 21938, 21719, 21753, 22104, 22099, 22262, 22052, 22034, 22029, 22117, 21986, 21496, 22119, 22073, 22126, 22135, 22142, 22056, 21807, 22148, 22150, 22151, 22161, 22178, 22163, 22069, 22125, 22173, 22176, 22179, 22180, 22185, 22187, 22192, 22193, 22195, 22198, 22084, 22162, 22203, 22209, 22153, 21557, 22225, 22186, 22234, 22201, 22239, 22260, 22246, 22250, 22085, 22265, 22261, 22259, 22270, 21626, 22274, 22275, 22277, 22278, 22279, 22293, 22281, 22283, 22291, 22304, 22300, 22302, 22312, 22308, 22309, 22318, 22305, 22311, 22263, 22327, 22326, 22350, 22325, 22330, 22243, 32038, 32006, 22355, 32075, 32089, 21667, 21713, 32108, 21603, 22264, 32100, 32118, 32068, 22183, 22149, 32112, 32011, 32141, 32139, 22204, 32121, 32097, 32156, 32063, 32037, 32160, 32124, 32036, 32149, 32166, 32150, 32093, 32179, 32198, 21609, 32104, 32146, 32136, 32177, 32079, 32067, 32155, 32193, 32255, 32209, 32211, 32222, 32123, 32204, 32205, 32190, 32228, 32231, 32259, 21504, 32216, 32212, 32242, 32248, 32247, 32249, 32263, 32213, 32214, 32265, 32220, 32047, 32274, 32273, 32128, 32275, 32226, 32061, 32246, 32289, 32188, 32192, 32290, 32291, 32294, 32300, 32309, 32243, 21954, 32215, 22071, 21499, 21799, 22021, 21008, 21001, 21083, 21276, 22020, 21897, 21763, 21525, 22287, 32116, 32315, 32317, 32318, 32230, 32306, 32319, 32329, 32321, 32326, 32325, 32332, 32328, 32298, 32241, 32343, 32208, 32345, 32276, 32302, 32354, 32356, 32357, 32288, 32096, 32362, 32365, 32369, 32371, 32304, 32379, 32303, 32372, 32293, 32197, 32380, 32382, 32383, 32386, 32389, 32301, 32367, 32394, 32395, 32396, 32399, 32404, 32400, 32401, 32402, 32715, 32407, 32408, 32387, 32105, 32409, 32415, 32413, 32414, 32416, 32417, 32181, 32420, 32421, 32427, 32425, 32447, 32428, 32429, 32772, 32431, 32342, 32432, 32433, 32434, 32442, 32435, 32437, 32440, 33625, 32552, 32439, 32448, 32451, 32453, 32459, 32460, 32338, 32232, 32466, 32471, 32472, 32475, 21435, 32476, 32464, 32480, 32482, 32418, 32483, 32485, 32486, 32491, 32495, 32183, 32497, 32499, 32377, 32501, 32503, 21190, 32504, 21191, 32519, 32509, 32510, 32514, 32518, 32520, 32521, 32522, 32523, 32524, 32525, 32526, 32527, 32528, 32529, 32490, 32530, 32531, 32532, 32533, 32534, 32535, 32536, 32537, 32538, 32540, 32541, 32051, 32544, 32545, 32546, 32548, 32549, 32339, 32551, 32358, 32462, 22214, 22251, 21188, 32560, 32144, 21810, 21467, 21924, 32101, 32039, 22112, 21425, 32261, 22063, 32187, 32436, 22165, 22170, 21422, 32392, 22269, 32161, 22145, 21956, 32153, 32310, 21594, 21487, 32224, 32199, 21196, 21571, 22226, 21779, 32282, 22232, 22128, 22335, 32558, 32559, 32515, 32561, 32562, 32411, 32563, 32555, 32567, 32487, 32512, 32572, 32502, 32571, 32494, 32576, 32674, 32554, 32307, 32578, 32505, 32582, 32584, 32585, 32569, 32277, 32602, 32624, 32591, 32592, 32574, 32596, 32597, 32604, 32600, 32601, 32603, 32605, 32606, 32609, 32484, 32669, 32611, 32612, 32613, 32614, 32615, 32617, 32618, 32989, 32493, 32608, 32853, 32619, 32620, 21500, 32625, 32627, 32626, 32628, 32632, 32629, 32565, 32630, 32750, 32631, 32633, 32637, 32635, 32638, 32639, 32640, 32642, 22242, 32645, 32646, 32647, 32648, 32649, 32650, 32570, 32651, 32652, 32654, 32658, 32656, 32657, 32660, 32598, 32662, 32664, 32667, 32671, 32677, 32679, 32681, 32683, 32684, 32686, 32688, 32690, 21988, 32691, 32692, 32693, 32694, 32695, 32697, 32700, 32701, 32702, 32706, 32711, 32703, 32704, 32705, 32708, 32746, 32713, 32714, 32659, 32720, 32721, 32723, 32731, 32740, 32699, 32736, 32728, 32727, 32733, 32737, 32729, 32641, 32748, 32749, 32751, 32758, 32786, 32759, 32768, 32764, 32763, 32765, 32820, 32783, 32808, 32767, 32766, 32824, 32769, 32770, 32159, 32634, 32773, 32587, 32774, 32776, 32777, 32779, 32780, 32781, 32782, 32734, 32785, 32787, 32788, 32789, 32790, 32793, 32795, 32794, 32655, 32797, 32799, 32800, 32801, 32802, 32806, 32809, 32810, 32811, 32813, 32817, 32812, 32814, 32829, 32815, 32775, 32819, 32818, 32821, 32747, 32823, 32756, 32826, 32831, 32832, 32834, 32835, 32836, 32863, 32837, 32852, 32843, 32860, 32842, 32846, 32847, 32848, 32850, 32855, 32856, 32861, 32865, 32866, 32867, 32868, 32869, 32870, 21096, 32871, 32872, 32873, 32874, 32877, 32878, 32879, 32887, 32880, 32888, 21197, 21569, 32881, 32882, 32229, 32885, 32886, 32889, 32890, 32892, 32753, 32893, 32894, 32897, 32964, 32901, 32862, 32898, 32899, 32974, 32900, 22210, 32902, 32903, 32905, 32908, 32909, 32517, 32911, 32912, 32913, 32914, 32916, 32917, 32922, 32921, 32925, 32931, 32926, 32927, 32928, 32933, 32934, 32936, 32940, 32876, 32595, 32944, 32959, 32945, 32948, 32950, 32951, 32952, 32955, 32954, 32957, 33067, 32962, 32965, 32967, 32370, 32968, 32969, 32970, 32971, 32975, 32976, 32977, 32979, 32980, 32983, 32981, 32982, 32986, 32987, 21508, 32938, 32991, 32932, 32988, 32943, 32992, 32997, 32995, 32998, 33000, 33001, 33002, 33004, 33006, 33007, 33010, 33008, 33009, 33012, 33011, 32825, 33024, 33015, 21993, 33016, 33017, 33018, 33020, 33021, 33027, 33029, 32376, 32003, 33031, 33032, 33030, 33036, 21224, 33040, 33041, 33042, 33046, 33049, 33013, 33057, 33055, 33056, 33064, 33063, 33061, 33060, 32996, 33065, 33066, 21168, 33068, 33070, 33071, 33087, 33073, 33076, 33078, 33081, 33088, 33123, 33142, 21589, 33096, 32738, 33274, 33101, 33102, 32741, 32985, 33107, 32956, 33110, 33112, 33120, 33115, 33047, 33026, 33116, 33117, 33118, 33119, 33099, 33053, 32930, 33108, 33109, 32816, 33128, 33127, 33105, 33129, 33132, 33043, 33133, 33134, 33135, 33136, 33097, 32716, 33158, 33146, 33148, 33111, 33083, 33161, 33091, 33163, 33124, 33164, 33140, 33166, 33167, 33168, 33170, 33094, 33157, 33144, 33172, 33173, 33174, 33171, 33143, 33153, 33152, 33181, 33150, 33147, 33160, 33182, 33155, 32994, 33090, 33156, 33141, 33187, 33188, 33189, 33190, 33191, 33192, 33194, 33195, 33196, 33197, 33200, 33201, 33202, 33203, 33204, 33175, 33214, 33216, 33222, 33223, 33186, 33224, 33165, 33225, 33221, 33226, 33227, 33183, 33228, 33231, 33229, 33079, 32993, 33232, 33233, 33205, 33178, 33236, 33237, 33238, 33239, 33241, 33125, 33242, 33245, 33248, 33249, 33149, 33218, 33254, 33255, 33256, 33139, 33151, 33259, 33260, 33261, 33263, 33265, 33266, 33267, 33268, 33272, 33185, 21545, 33275, 33278, 33291, 33292, 33093, 33282, 33206, 33283, 33207, 33284, 33289, 33286, 33287, 33244, 33209, 33253, 33293, 33294, 33296, 33297, 33299, 33300, 33302, 33301, 33303, 33304, 33219, 33180, 33305, 33306, 33177, 33240, 33311, 33258, 33313, 33154, 33314, 33251, 32875, 33234, 33235, 33318, 33176, 33089, 33084, 33329, 33330, 33335, 33351, 33338, 33269, 33336, 33339, 33341, 33342, 33346, 33343, 33344, 33345, 33279, 33348, 33347, 33349, 33252, 33369, 33360, 33361, 33363, 33312, 33362, 33364, 33365, 33367, 33368, 32973, 33370, 33372, 33392, 33471, 33375, 33374, 33376, 33328, 33377, 33379, 33380, 33382, 33383, 33386, 33387, 33388, 33452, 33389, 33058, 33098, 33394, 33393, 33080, 33398, 33397, 33396, 33399, 33402, 33406, 33408, 33409, 33410, 33412, 33413, 33414, 33416, 33454, 33456, 33417, 33418, 33419, 33421, 33423, 33422, 33426, 33432, 33504, 33428, 33430, 33425, 33433, 33435, 33434, 33462, 33627, 33438, 33925, 33439, 33441, 33443, 33444, 33445, 33446, 33447, 33449, 33453, 33455, 33458, 33463, 33464, 33465, 33470, 33407, 33468, 33474, 33476, 33475, 33130, 33378, 33478, 33479, 33480, 33483, 33491, 33482, 33484, 32978, 33485, 33488, 33490, 33492, 33493, 33494, 33086, 33497, 33499, 33500, 33333, 33050, 32424, 33501, 33502, 33503, 33505, 33506, 33507, 33508, 33509, 33510, 33512, 33515, 33514, 33516, 33250, 33095, 33517, 33518, 33519, 33521, 33523, 33524, 33525, 33526, 33527, 33298, 33528, 33530, 33531, 33532, 33533, 33537, 21868, 33539, 33541, 33540, 33542, 33544, 33543, 33545, 33547, 33548, 33549, 33550, 33551, 33552, 22130, 33553, 33554, 33555, 33535, 33557, 33556, 33560, 33558, 33562, 33561, 33563, 33564, 33566, 33568, 33569, 33570, 33571, 33459, 33575, 33576, 33577, 33322, 33578, 33579, 33581, 33582, 33584, 33585, 33586, 33588, 33589, 33590, 33587, 33591, 33595, 33594, 33596, 33597, 33605, 33603, 33606, 33608, 33607, 33609, 33610, 33611, 33340, 33632, 33626, 33633, 33628, 33285, 21982, 33634, 33636, 33638, 33637, 33668, 33644, 33642, 33643, 33645, 33646, 33647, 33648, 33649, 33650, 33651, 33670, 33652, 33655, 33654, 33656, 33658, 33669, 33660, 33661, 21639, 33662, 33664, 33665, 33666, 33684, 33673, 33674, 33675, 33676, 33680, 72029, 33681, 32644, 33683, 72010, 33688, 33687, 33689, 33691, 33690, 33692, 33696, 33695, 33131, 72003, 21211, 21550, 72007, 33052, 33700, 33701, 33702, 72005, 33704, 21264, 33705, 33706, 33851, 33710, 72016, 72015, 72001, 33713, 33714, 33715, 33717, 33722, 33723, 33724, 33726, 33727, 32792, 33728, 33730, 33731, 33736, 33699, 33534, 33740, 33741, 33742, 33746, 33747, 33748, 33749, 33751, 33750, 33752, 33754, 33756, 33755, 72012, 72018, 72020, 72019, 72160, 72022, 72023, 72025, 72247, 72154, 72038, 72157, 72032, 72036, 72034, 33764, 33766, 33767, 33768, 72040, 33774, 72153, 33771, 33772, 33773, 72159, 72156, 72136, 72047, 72048, 72049, 72052, 33777, 33778, 33779, 33781, 72053, 33782, 33854, 33085, 33784, 33787, 33788, 33257, 72249, 33718, 33806, 33849, 33815, 33850, 72145, 33794, 33797, 33072, 22159, 72134, 33823, 33805, 33825, 33828, 33830, 33852, 33836, 33837, 72111, 72113, 72112, 33838, 33839, 33848, 33842, 33846, 33841, 72109, 33807, 72114, 72118, 72120, 72119, 72121, 72122, 72124, 72123, 72126, 72128, 72129, 33853, 72137, 72138, 72140, 72139, 72141, 72143, 72142, 72144, 72147, 72148, 72150, 72151, 72152, 33855, 33856, 33858, 33859, 72168, 72170, 33865, 33864, 72174, 72171, 72251, 33866, 72173, 33867, 36001, 33883, 33872, 33873, 33874, 33875, 33942, 33880, 33881, 33884, 33885, 72175, 72177, 72176, 32272, 33887, 33888, 72183, 72013, 21796, 21996, 22041, 33138, 32143, 33895, 33896, 33897, 33898, 33894, 33900, 33902, 33972, 33903, 33906, 33909, 33910, 72185, 33928, 33911, 72194, 33916, 33947, 33955, 33919, 33920, 72186, 72188, 72189, 33941, 33921, 33922, 72190, 21925, 72192, 72193, 72195, 72196, 72199, 72200, 33924, 72201, 72202, 72203, 72204, 32148, 33932, 33933, 33934, 33939, 72207, 72217, 72255, 72253, 72260, 72257, 72256, 72259, 72254, 72258, 33938, 33940, 72221, 33943, 32346, 21269, 33935, 33936, 72223, 72180, 33945, 72227, 33958, 33948, 33949, 72264, 33983, 33950, 33952, 32233, 36005, 32351, 72228, 33954, 33961, 72230, 72231, 33957, 33963, 33959, 72232, 33960, 33962, 72237, 33964, 72236, 72233, 33956, 33965, 33981, 33966, 72235, 72234, 33967, 72238, 33968, 72240, 33973, 33977, 33974, 72309, 33975, 33976, 33978, 72244, 33979, 32201, 33984, 32210, 72265, 72266, 33982, 72267, 72269, 33985, 33986, 36002, 22217, 33988, 72270, 72271, 72273, 33989, 36000, 33991, 33994, 33992, 36009, 33996, 33995, 21556, 36004, 36006, 36007, 36008, 72279, 72224, 36013, 36015, 36016, 36017, 36018, 36010, 21630, 72280, 72281, 36019, 72287, 36020, 32689, 72288, 36023, 32712, 72290, 72292, 36021, 36022, 22095, 36024, 36027, 36028, 36025, 72294, 36026, 36030, 36029, 36032, 36031, 36033, 72304, 72301, 72302, 36034, 36035, 36036, 36037, 32581, 72303, 36038, 36041, 36042, 36040, 36056, 36043, 72278, 36045, 36046, 36047, 36048, 72306, 36049, 36050, 36057, 36051, 36062, 36054, 36065, 32907, 36058, 72308, 22315, 36061, 36069, 72310, 36070, 36063, 36071, 72312, 72311, 72313, 36077, 36078, 72316, 36079, 22223, 33122, 36081, 72318, 72317, 36082, 22110, 36083, 36093, 36084, 36091, 36085, 36086, 36092, 36089, 36087, 36088, 72321, 72320, 36095, 72319, 36103, 36108, 36109, 36110, 72226, 36107, 36106, 13051, 36105, 72324, 72325, 21776, 21284, 72326, 72327, 21754, 32001, 32616, 21674, 72116, 72117, 22129, 32668, 21246, 21252, 21474, 21675, 21651, 21495, 32739, 21455, 21076, 21405, 32463, 36099, 22155, 21240, 21320, 21879, 21479, 32080, 21475, 21066, 32151, 21251, 33678, 33679, 33538, 33677, 33686, 32254, 32757, 32430, 21678, 21558, 21113, 32314, 21321, 32002, 21334, 22286, 21009, 21077, 21112, 21254, 32122, 32320, 21494, 32388
Product: Achieva 1.5T Conversion, Magnetic Resonance System
Model / REF:
781283
781346
Lot Numbers:
Serial No. 39025, 8020, 39027, 39060, 39016, 39079, 39022, 39001, 8467, 39013, 39006, 39004, 39007, 39008, 39011, 39010, 39012, 39026, 39023, 39028, 39032, 39029, 39034, 39030, 39052, 39053, 39064, 39039, 39054, 39056, 39036, 39041, 39038, 39065, 39066, 39067, 39040, 39057, 39042, 39072, 39071, 39073, 39074, 39058, 39059, 39078, 39081, 39075, 39083, 39082, 39085, 39077, 39086, 39084, 39080, 39062, 39089, 39092, 39096, 39098, 39100, 39094, 39088, 39091, 39093, 39104, 39105, 75000, 75007, 39099, 39107, 75001, 39102, 75002, 39097, 75003, 75004, 75015, 39095, 75031, 8276, 75011, 75005, 10512, 75010, 75049, 10189, 10048, 8069, 10006, 8312, 8520, 18588, 18052, 5547, 10015, 8740, 8415, 10539, 75009, 10194, 8714, 5243, 10172, 39090, 18737, 8727, 8367, 8289, 39061, 75068, 8782, 75008, 8361, 8371
Product: Achieva 1.5T Initial, Magnetic Resonance System
Model / REF:
781178
Lot Numbers:
Serial No. 20126, 20129, 20062, 20297, 20307, 20150, 20248, 20096, 20252, 20257, 20282, 20149, 20072, 20277, 20281, 20185, 20081, 20018, 20042, 20139, 20113, 20095, 20133, 20124, 20194, 20217, 20080, 20241, 20222, 20162, 20010, 20320, 20259, 20167, 20114, 20130, 20335, 20326, 20323, 20274, 20157, 20040, 20117, 20037, 20098, 20079, 20258, 20087, 20043, 20094, 20191, 20088, 20331, 20172, 20028, 20210, 20179, 20291, 20050, 20173, 20303, 20023, 20224, 20047, 20066, 20085, 20056, 20083, 20230
Product: Achieva 3.0T, Magnetic Resonance System
Model / REF:
781177
781277
781278
781344
781345
Lot Numbers:
Serial No. 17108, 24070, 24114, 34066, 24053, 17235, 17256, 17244, 17114, 34028, 38018, 17049, 17217, 38033, 17319, 17347, 17094, 34065, 17430, 34085, 17392, 17385, 17494, 17384, 17461, 17119, 17043, 17561, 17453, 17093, 17414, 17393, 17365, 17216, 24040, 17035, 17017, 17039, 17025, 17051, 17008, 17091, 17126, 17099, 17166, 17171, 17238, 17189, 17234, 17233, 17279, 17185, 17257, 17343, 17294, 17334, 17295, 17243, 17285, 17057, 17118, 17178, 17374, 17139, 17371, 17379, 17427, 17402, 17359, 17394, 17469, 24014, 17412, 17413, 17452, 17358, 17431, 17446, 17451, 17404, 17535, 17433, 17443, 17424, 17144, 17147, 17448, 17324, 17161, 24009, 17150, 17591, 17500, 24010, 17361, 24005, 17596, 17498, 17362, 17617, 17418, 24049, 24082, 17432, 17011, 24056, 24062, 24068, 24081, 24079, 17607, 24052, 24091, 24096, 24099, 34022, 24116, 17450, 24120, 24130, 24125, 17426, 24131, 34002, 17349, 34023, 24135, 24138, 34043, 34094, 17167, 34086, 34047, 38002, 34033, 34011, 34052, 34095, 38003, 34082, 34109, 34113, 34120, 17124, 34104, 34123, 38012, 38017, 24154, 34077, 38022, 34122, 34139, 17072, 17131, 17377, 24060, 34138, 34135, 34125, 34144, 34130, 38009, 34208, 34056, 38031, 34106, 38044, 38079, 34140, 34118, 34159, 34160, 38046, 34165, 38042, 38049, 38060, 38054, 38057, 17435, 34206, 38059, 38064, 34020, 38072, 38067, 38069, 38043, 34038, 38073, 38078, 34220, 34226, 34225, 38021, 34074, 34228, 38056, 38082, 34230, 38074, 38085, 38086, 38061, 38087, 38090, 34232, 38093, 38095, 34207, 38098, 38099, 38101, 38055, 34115, 38104, 34213, 34234, 38112, 34200, 38114, 38113, 34231, 38115, 34235, 34239, 34240, 34241, 34242, 38124, 38128, 38108, 38130, 38220, 38144, 38137, 38139, 38140, 38141, 38143, 38145, 38151, 38152, 38154, 38158, 38162, 34253, 34247, 38167, 38160, 38150, 38133, 38171, 38172, 38169, 38174, 38170, 38181, 34254, 38185, 38186, 38197, 38187, 38188, 38189, 38190, 38191, 34258, 34260, 34263, 34264, 38193, 38194, 38200, 38196, 34255, 34268, 34269, 38205, 38206, 38207, 38209, 38210, 34270, 38216, 38223, 34256, 17168, 24019, 38157, 38227, 34272, 38228, 34273, 38232, 38229, 38230, 38231, 38234, 34271, 34274, 38241, 34275, 38237, 24097, 38238, 34276, 38240, 38244, 38245, 38246, 38247, 38248, 38249, 38269, 38251, 38253, 38254, 38255, 38256, 38258, 38260, 17558, 34281, 34282, 38261, 38262, 17134, 38266, 38212, 38265, 38173, 38268, 38270, 38271, 38272, 17304, 38233, 38273, 38257, 38274, 38276, 38279, 17380, 38264, 34286, 38280, 38283, 38282, 38285, 17316, 38288, 38291, 34285, 38293, 34287, 38295, 38297, 38298, 38299, 24059, 34288, 38267, 34289, 38278, 38302, 38292, 38303, 17296, 38304, 34290, 38307, 34291, 38252, 38284, 38312, 38313, 38314, 38215, 38315, 38236, 34293, 38016, 38318, 38319, 38320, 38321, 38322, 38323, 38324, 34294, 34295, 38327, 38328, 38329, 17034, 38330, 38331, 38332, 38287, 38336, 38337, 34297, 38338, 34298, 38339, 34299, 38340, 38335, 34300, 38343, 38344, 38345, 38346, 38347, 38349, 34301, 38351, 34304, 38355, 38359, 38360, 38361, 38363, 17038, 34305, 34306, 73002, 73003, 73004, 74001, 74002, 73009, 73008, 73005, 74027, 24038, 34073, 73006, 74004, 38354, 34308, 34312, 74005, 74020, 74009, 74007, 34309, 74010, 74021, 17042, 74026, 74029, 74030, 17497, 38127, 74032, 74033, 74046, 74034, 74035, 38004, 34071, 34029, 74044, 74041, 73010, 74039, 74047, 74048, 17075, 17460, 74052, 34030, 17270, 34034, 17070, 34143, 38103, 17251, 24089, 17456, 17001, 34201, 17445, 24050, 38007, 17149, 17085, 24045, 34001, 17179, 38341, 17170, 17523, 17551, 24037, 17187, 17056, 17599, 17102, 17313, 24078, 17079, 17130, 17103, 17142, 17146, 17183, 17437
Product: Achieva 3.0T for PET, Magnetic Resonance System
Model / REF:
781477
Lot Numbers:
Serial No. 43006
Product: Achieva 3.0TX for PET, Magnetic Resonance System
Model / REF:
781479
Lot Numbers:
Serial No. 43102
Product: Achieva XR, Magnetic Resonance System
Model / REF:
781153
781253
Lot Numbers:
Serial No. 35075, 23028, 23017, 23021, 35006, 35015, 35016, 35021, 23009, 23003, 23031, 23005, 23035, 23040, 35007, 35022, 35025, 35028, 35024, 35035, 35039, 35049, 35055, 35013, 35064, 35063, 35071, 35068, 35069, 35070, 35067, 35081, 35011, 35083, 35084, 35082, 23020, 23038, 35076, 35020, 35085, 35050, 35057, 23014, 35004, 35061, 35074, 23004, 23029
Product: Enterprise 1.5T, Magnetic Resonance System
Model / REF:
781145
Lot Numbers:
Serial No. 10709, 10682, 10678, 10729, 10217, 10031, 10092, 10111, 10715, 10074, 10121, 10122, 10119, 10732, 10775, 10795, 10041, 10711, 10144, 10792, 10787, 10689, 10218, 10704, 10693, 10685, 10696, 10687, 10726, 10797, 10799, 10789, 10790
Product: Evolution Upgrade 3.0T, Magnetic Resonance System
Model / REF:
782143
Lot Numbers:
Serial No. 85699
Product: GYROSCAN ACS-NT, Magnetic Resonance System
Model / REF:
78107
Lot Numbers:
Serial No. 5533, 5414, 5245, 5542, 5300, 5227, 5472, 5193, 5413, 5216, 5029, 5460, 5437, 5213, 5295, 5302, 5387, 5468, 5098, 5339, 5156, 5349, 5334, 5513, 5461, 5545, 5177, 5564, 5102, 5134, 5288, 5168, 5428, 5411, 5519, 5323, 5561, 5230, 5142, 5082, 5014, 5110, 5052, 5379, 5137, 5389, 5403, 5232, 5556, 5065
Product: GYROSCAN T10-NT, Magnetic Resonance System
Model / REF:
78108
Lot Numbers:
Serial No. 4221, 4332, 4209, 4235, 4083, 4368, 4090, 4171, 4182, 4217, 4276, 4360, 4115, 4157, 4181, 4215, 4234, 4238, 4239, 4242, 4245, 4277, 4351, 4399, 4029, 4072, 4097, 4110, 4228, 4375, 4408, 4284, 4376, 4396, 4168, 4224, 4289, 4377, 4014, 4081
Product: GYROSCAN T5, Magnetic Resonance System
Model / REF:
78104
Lot Numbers:
Serial No. 605, 889, 915, 938, 663, 600, 891
Product: GYROSCAN T5-NT, Magnetic Resonance System
Model / REF:
78106
Lot Numbers:
Serial No. 1194, 1249, 1009, 1161, 1091, 1130, 1183, 1196, 1260, 1151, 1022, 1126, 1176, 1211, 1238, 1256, 1070, 1233, 1270, 1198, 1234, 1148, 1128, 1245
Product: Ingenia 1.5T, Magnetic Resonance System
Model / REF:
781396
781315
782115
781341
782101
UPC Codes:
884838055322
884838099715
884838099043
884838098275
Lot Numbers:
Serial Numbers [Extensive List Available in Source Data]
Product: Ingenia 1.5T CX, Magnetic Resonance System
Model / REF:
781261
781262
UPC Codes:
884838068438
Lot Numbers:
Serial Numbers [Extensive List Available in Source Data]
Product: Ingenia 1.5T S, Magnetic Resonance System
Model / REF:
781347
UPC Codes:
884838068421
Lot Numbers:
Serial Numbers [Extensive List Available in Source Data]
Product: Ingenia 3.0T, Magnetic Resonance System
Model / REF:
781377
781342
782103
UPC Codes:
884838009813
884838055339
884838098299
Lot Numbers:
Serial Numbers [Extensive List Available in Source Data]
Product: Ingenia 3.0T CX, Magnetic Resonance System
Model / REF:
781271
782105
UPC Codes:
884838068452
884838098312
Lot Numbers:
Serial Numbers [Extensive List Available in Source Data]
Product: Ingenia Ambition S, Magnetic Resonance System
Model / REF:
782133
782139
781359
782108
UPC Codes:
884838090057
884838098343
884838108639
Lot Numbers:
Serial Numbers [Extensive List Available in Source Data]
Product: Ingenia Ambition X, Magnetic Resonance System
Model / REF:
781359
782109
782138
UPC Codes:
884838090040
884838098350
884838108622
Lot Numbers:
Serial Numbers [Extensive List Available in Source Data]
Product: Ingenia Elition S, Magnetic Resonance System
Model / REF:
781357
782106
UPC Codes:
884838088108
884838098329
Lot Numbers:
Serial Numbers [Extensive List Available in Source Data]
Product: Ingenia Elition X, Magnetic Resonance System
Model / REF:
782136
781358
78217
782119
UPC Codes:
884838108622
884838098336
884838104129
884838108608
Lot Numbers:
Serial Numbers [Extensive List Available in Source Data]
Product: Intera 0.5T Standard, Magnetic Resonance System
Model / REF:
781101
Lot Numbers:
Serial No. 6047, 6018, 6023, 6027, 6031, 6044, 6060, 10306, 6015, 6061, 6025, 6054, 6001, 6066
Product: Intera 1.0T Omni/Stellar, Magnetic Resonance System
Model / REF:
781102
Lot Numbers:
Serial No. 7069, 7213, 7238, 10045, 7248, 10341, 10073, 7020, 7247, 7081, 7141, 7120, 7116, 10334, 10047, 7226, 7111, 7203, 7117, 7022, 7031, 7085, 7051, 7156, 7215, 10001, 10328, 7018
Product: Intera 1.0T Power/Pulsar, Magnetic Resonance System
Model / REF:
781103
Lot Numbers:
Serial No. 7062, 7164, 7102, 7113, 7084, 10381, 7097, 10383, 10384, 10391, 7150, 7074, 7237, 7190, 7198, 10413, 10382, 7103, 10071
Product: Intera 1.5T, Magnetic Resonance System
Model / REF:
781195
781295
Lot Numbers:
Serial Numbers [Extensive List Available in Source Data]
Product: Intera 1.5T Achieva IT Nova, Magnetic Resonance System
Model / REF:
781175
Lot Numbers:
Serial No. 15002, 15003
Product: Intera 1.5T Achieva Nova, Magnetic Resonance System
Model / REF:
781172
Lot Numbers:
Serial No. 12144, 12075, 12031, 12015, 12056, 12051, 12107, 12078, 12065, 12045, 12046, 12026, 12105, 12062, 12111, 12077, 12044, 12049, 12119, 12081, 12161, 12099, 12138, 12020, 12139, 12102, 12069, 12152, 12004, 12086, 12122, 12128, 12052, 12063, 12005, 12050, 12141, 12025, 12106, 12146, 12001, 11010, 12074, 12073, 12079, 12057
Product: Intera 1.5T Achieva Nova-Dual, Magnetic Resonance System
Model / REF:
781173
Lot Numbers:
Serial No. 13010, 13013, 13028, 13017, 13033, 13058, 13061, 13071, 13056, 13074, 13057, 13044, 13060, 13027, 13067, 13049, 13048, 13043, 13008, 13012
Product: Intera 1.5T Explorer/Nova Dual, Magnetic Resonance System
Model / REF:
781108
Lot Numbers:
Serial No. 8918, 10035, 8803, 10037, 9025, 10022, 10638, 10640, 8743, 8651, 10091, 8690
Product: Intera 1.5T Master/Nova, Magnetic Resonance System
Model / REF:
781106
Lot Numbers:
Serial No. 8648, 8650, 8400, 8668, 8849, 8788, 8754, 8603, 8733, 8488, 8928, 8866, 8224, 8368, 8254, 10131, 8379, 8827, 8482, 8050, 8018, 8356, 8205, 8362, 8800, 8793, 8437, 8313, 8924, 9023, 10134, 10016, 8984, 8325, 8248, 8947, 8479, 8195, 8940, 10536, 10567, 8364, 9028, 8593, 8136, 10059, 8448, 8345, 8363, 8678, 9018, 8775, 8423, 8410, 8013, 8259, 8700, 8284, 8955, 8539, 10556, 8547, 8980, 8720, 8565, 8858, 8672, 8373, 10568, 8177, 8150, 8501, 9015, 8317, 8941, 8265, 8901, 10197, 8744, 10094, 8360, 8295, 10110, 8915, 8429, 8226, 8976, 8726, 8160, 8214, 8444, 9014, 8564, 8134, 8009, 8159, 10133, 8908, 8152, 10195, 8071, 8324, 8147, 8161, 8606, 8173, 8068
Product: Intera 1.5T Omni/Stellar, Magnetic Resonance System
Model / REF:
781104
Lot Numbers:
Serial No. 8483, 8526, 8257, 8171, 8731, 8126, 10403, 10401, 10410, 10407, 8266, 8286, 8246, 8725, 8556, 8338, 8625, 8516, 8332, 8138, 8921, 8359
Product: Intera 1.5T Power/Pulsar, Magnetic Resonance System
Model / REF:
781105
Lot Numbers:
Serial No. 8342, 8104, 8899, 8557, 8797, 8665, 8154, 8590, 8333, 8418, 8615, 8963, 8846, 8216, 8112, 8296, 8384, 8626, 8093, 8217, 10209, 10093, 8738, 10212, 8622, 8040, 8748, 8695, 8188, 8326, 8684, 8854, 8878, 8936, 8974, 8935, 10156, 10140, 8337, 10510, 10920, 10488, 10517, 8588, 8158, 8405, 8610, 8017, 10479, 8381, 9003, 10163, 10470, 9027, 8032, 8207, 8280, 8283, 8293, 8439, 8618, 8688, 10232, 8838, 8605, 10120, 10129, 8420, 10080, 8546, 8548, 8434, 10500, 10187, 9029, 8676, 8836, 8685, 8469, 8505, 8470, 8277, 8991, 8510, 8633, 8357, 8048, 10159, 8643, 8414, 8708, 8925, 8130, 8617, 8818, 8027, 10039, 8335, 8952, 8663, 8549, 8034, 10108, 8956, 8806, 8916, 8791, 8393, 8058, 8455, 8033, 8558, 8579, 10178, 10526
Product: Intera 1.5T R11, Magnetic Resonance System
Model / REF:
781170
Lot Numbers:
Serial No. 18070, 18021, 18025, 18110, 18019, 18009, 18055, 18064, 18095, 18105, 18002, 18082, 18083, 18039, 18108, 18032, 18071, 18092, 18074, 18030, 18011, 18049, 18066, 18097, 18031
Product: Intera 3.0T Quasar Dual, Magnetic Resonance System
Model / REF:
781150
Lot Numbers:
Serial No. 5729, 10138, 10123, 10746, 10136, 10103, 5714, 10182, 5704
Product: Intera Achieva 1.5T Pulsar, Magnetic Resonance System
Model / REF:
781171
Lot Numbers:
Serial No. 11069, 11024, 11048, 11090, 11049, 11058, 11013, 11036, 11045, 11087, 11061, 11009, 11060, 11044, 11039, 11043, 11020, 11007, 11025, 11094, 11033, 11059, 11019, 11068
Product: Intera CV, Magnetic Resonance System
Model / REF:
781107
Lot Numbers:
Serial No. 8528, 8653, 8907, 8869, 8703, 9017, 8756, 8014
Product: MR 5300, Magnetic Resonance System
Model / REF:
782110
UPC Codes:
884838099364
Lot Numbers:
Serial No. 63029, 63087, 63014, 63103, 63000, 63006, 63007, 63001, 63008, 63010, 63013, 63015, 63021, 63022, 63039, 63023, 63024, 63026, 63025, 63028, 63030, 63031, 63038, 63054, 63041, 63042, 63046, 63043, 63044, 63047, 63049, 63050, 63012, 63051, 63053, 63032, 63057, 63060, 63094, 63064, 63063, 63068, 63079, 63066, 63072, 63071, 63070, 63082, 63074, 63076, 63083, 63202, 63085, 63019, 63086, 63093, 63091, 63090, 63096, 63097, 63165, 63075, 63099, 63104, 63106, 63105, 63108, 63009, 63107, 63109, 63111, 63112, 63119, 63115, 63116, 63127, 63121, 63125, 63069, 63034, 63130, 63036, 63058, 63155, 63144, 63140, 63141, 63146, 63033, 63149, 63151, 63150, 63153, 63154, 63157, 63161, 63080, 63098, 63018, 63166, 63169, 63175, 63176, 63178, 63177, 63191, 63197, 63188, 63183, 63186, 63187, 63198, 63195, 63199, 63262, 63210, 63148, 63223, 63224, 63239, 63228, 63229, 63128, 63261, 63260, 63122, 63243, 63248, 63252, 63027, 63266, 63267, 63268, 63276, 63271, 63283, 63287, 63286, 63306, 63272, 63292, 63309, 63135, 63311, 63078, 63190, 63174, 63201, 63331, 63168, 63139, 63290, 63220, 63288, 63304, 63264, 63138, 63402, 63016, 63270, 63305, 63282, 63285, 63265, 63289, 63303
Product: MR 7700, Magnetic Resonance System
Model / REF:
782120
UPC Codes:
884838104112
Lot Numbers:
Serial No. 65051, 65005, 65000, 65002, 65003, 65001, 65004, 65009, 65012, 65013, 65015, 65017, 65020, 65019, 65021, 65023, 65024, 65025, 65031, 65006, 65032, 65035, 65034, 65038, 65030, 65037
Product: SmartPath to dStream for 1.5T, Magnetic Resonance System
Model / REF:
781260
782112
UPC Codes:
884838095076
884838098886
Lot Numbers:
Serial Numbers [Extensive List Available in Source Data]
Product: SmartPath to dStream for XR and 3.0T, Magnetic Resonance System
Model / REF:
781270
782113
782129
UPC Codes:
884838098909
884838105805
Lot Numbers:
Serial No. 17271, 38281, 17560, 17252, 34202, 34153, 34127, 38311, 34128, 34172, 17470, 34131, 24021, 24093, 17258, 38290, 35041, 38105, 34110, 17449, 38010, 34212, 38142, 34117, 38166, 38106, 34129, 38310, 38195, 38219, 24077, 24039, 38222, 17521, 34072, 38117, 38070, 34055, 17439, 17455, 38075

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 94233
Status: Active
Manufacturer: Philips North America Llc
Sold By: Philips authorized medical equipment distributors; specialized hospital supply chains
Manufactured In: United States
Units Affected: 41 products (1,921 units; 115 units; 69 units; 511 units; 1 unit; 1 unit; 49 units; 33 units; 1 unit; 50 units; 40 units; 7 units; 23 units; 2,242 units; 143 units; 135 units; 1,509 units; 342 units; 344 units; 404 units; 131 units; 448 units; 14 units; 27 units; 19 units; 347 units; 2 units; 46 units; 20 units; 12 units; 107 units; 22 units; 115 units; 25 units; 9 units; 24 units; 8 units; 166 units; 26 units; 672 units; 41 units)
Distributed To: Nationwide

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AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES ยท Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.