Device recall

SmartPath to dStream for 1.5T, SmartPath to dStream for 3.0T, SmartPath to dStream for XR and 3.0T, SmartPath to Ingenia Elition X; Model Numbers (REF): 1. 781260 (1.5T), 2. 782112 (1.5T), 3. 782146 (1.5T), 4. 782145 (3.0T), 5. 781270 (XR and 3.0T), 6. 782113 (XR and 3.0T), 7. 782129 (XR and 3.0T), 8. 782118 (Ingenia Elition X), 9. 782144 (Ingenia Elition X);

FDA recall source

Recall number: Z-3243-2026
Event id: 99769
Status: Ongoing
FDA classification: Class II
Recalling firm: Philips North America Llc
Report date: Sep 30, 2026
Posted: Sep 18, 2026
Initiated: Aug 21, 2026
Center classification date: Sep 18, 2026
Product code: LNH
Device type: System, Nuclear Magnetic Resonance Imaging
Reason: 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.
Root cause: Software design
Quantity: 965
Code info: 1. Model Number (System): 781260 (1.5T) UDI-DI: 884838095076; Serial Numbers: 32953, 8750, 8554, 9013, 18574, 18801, 18988, 20211, 32923, 32778, 8156, 8752, 10139, 10164, 21379, 21175, 32445, 11100, 18583, 18746, 18761, 18853, 18965, 18986, 20003, 21138, 21349, 21384, 21748, 22144, 22266, 30037, 30139, 30146, 32223, 32458, 33044, 33045, 33220, 33246, 33716, 72250, 5572, 8240, 8734, 8808, 8985, 10183, 12030, 20282, 21466, 32643, 8713, 8917, 10087, 10130, 18673, 18701, 18803, 32283, 22220, 8087, 8215, 8923, 13026, 22127, 32467, 8427, 10528, 8862, 21333, 21710, 21768, 22255, 22256, 22257, 21554, 22070, 32049, 5425, 5447, 5484, 5536, 5539, 5550, 8001, 8084, 8096, 8110, 8175, 8263, 8315, 8318, 8321, 8387, 8401, 8407, 8476, 8486, 8559, 8601, 8611, 8642, 8704, 8804, 8885, 9020, 9024, 10008, 10033, 10061, 10075, 10117, 10170, 10174, 10191, 10717, 11000, 11031, 11062, 11102, 11108, 12121, 18013, 18565, 18631, 18690, 18697, 18894, 18906, 18938, 18957, 20057, 20070, 20160, 21015, 21018, 21020, 21082, 21453, 21814, 21932, 21979, 22194, 30097, 32099, 32134, 32163, 32164, 32176, 32333, 32334, 32340, 32341, 32454, 32636, 32710, 32752, 39018, 39031, 39103, 5499, 5505, 8657, 21296, 32680, 10029, 18987, 8054, 8350, 11064, 11072, 12053, 13011, 18575, 18718, 18720, 18940, 20032, 20055, 20206, 20295, 21004, 21087, 21091, 21141, 21184, 21200, 21210, 21223, 21247, 21261, 21312, 21347, 21451, 21555, 21576, 21582, 21611, 21680, 21691, 21694, 21737, 21739, 21755, 21863, 21878, 21912, 21942, 22017, 22018, 22086, 22093, 22103, 22171, 22240, 30132, 30239, 32140, 32158, 32285, 32441, 32449, 32822, 33023, 33051, 33106, 33126, 33179, 39005, 72081, 8213, 5466, 5537, 5546, 8045, 8311, 8395, 8424, 8431, 8641, 8667, 8712, 8786, 8840, 10102, 10185, 10220, 10457, 10552, 10554, 11017, 11046, 12036, 13001, 18069, 18101, 18509, 18511, 18548, 18655, 18788, 18970, 20111, 20132, 20165, 20196, 20413, 21032, 21362, 21551, 21565, 21623, 21746, 21809, 21890, 21892, 22044, 22055, 22182, 22296, 22299, 30033, 32264, 32316, 32478, 32492, 32506, 32670, 32805, 32849, 32990, 33100, 39037, 72239, 72243, 5511, 8012, 8057, 8060, 8094, 8309, 8481, 8517, 8531, 8561, 8711, 8724, 8843, 8857, 8887, 8896, 8949, 10007, 10151, 10498, 10513, 10719, 10906, 10913, 11005, 11042, 11091, 12055, 12114, 12120, 13029, 13046, 13047, 13062, 13073, 18017, 18107, 18524, 18670, 18704, 18929, 18954, 20002, 20011, 20035, 20187, 20195, 20209, 20237, 20263, 20278, 20288, 20302, 21089, 21129, 21182, 21209, 21213, 21222, 21249, 21278, 21326, 21355, 21403, 21448, 21482, 21519, 21560, 21579, 21583, 21640, 21697, 21759, 21780, 21792, 21969, 21987, 22013, 22031, 22098, 22123, 22157, 22175, 22184, 32132, 32217, 32236, 32258, 39009, 21804, 13069, 33352, 22237, 33062, 8091, 10230, 11022, 12169, 18610, 18800, 18948, 21067, 21481, 32709, 33215, 8639, 8686, 18663, 18699, 21019, 21023, 21359, 32119, 32742, 8086, 8292, 10543, 21591, 22189, 32573, 32145, 21994, 21995, 10086, 10556, 8983, 18985, 8166, 8723, 10161, 10530, 22301, 22342, 32391, 8168, 8451, 21498, 18512, 21929, 22152, 21143, 21612, 22233, 22273, 22285, 8616, 20112, 32311, 32513, 33198, 33366, 10570, 11018, 8354, 8694, 9006, 32200, 5479, 8485, 8550, 8746, 8779, 8799, 9032, 10461, 10716, 12047, 21133, 21294, 21577, 32839, 32845, 11085, 12134, 21438, 22100, 22137, 32094, 32147, 32221, 32296, 32374, 32405, 32059, 32180, 8392, 12115, 20182, 22107, 32359, 32245, 8492, 8895, 10079, 20151, 20152, 20198, 21084, 21454, 21880, 32807, 21880, 5475, 8100, 8352, 8560, 8578, 8630, 8760, 8772, 8835, 8906, 8971, 8975, 9001, 10036, 10196, 10482, 10703, 12033, 12034, 18558, 18726, 20226, 20303, 21108, 21290, 21664, 21665, 21788, 32131, 32174, 33385; 2. Model Number (System): 782112 (1.5T) UDI-DI: 884838098886; Serial Numbers: 18857, 21252, 21684, 30313, 32250, 8266, 8552, 18776, 21771, 21803, 22048, 30058, 30089, 32106, 32400, 32487, 32827, 32897, 33000, 33103, 33189, 33275, 33371, 33404, 33494, 33545, 33547, 33565, 33568, 33749, 33751, 18942, 20224, 21495, 21608, 21726, 22247, 32295, 32673, 32762, 33019, 32724, 30054, 32229, 32265, 32418, 32419, 32558, 32596, 32803, 33033, 33248, 33249, 33470, 33647, 72204, 72208, 22141, 8798, 10169, 10190, 10474, 10521, 12029, 13021, 13024, 18810, 21077, 21090, 21158, 21685, 21740, 22027, 39106, 8298, 18714, 18510, 32469, 21940, 32539, 8573, 10128, 18995, 20099, 20159, 21433, 21893, 22290, 32457, 32577, 32580, 32661, 32719, 32725, 32798, 33082, 75012, 8109, 8876, 10222, 18520, 18651, 18892, 18950, 20171, 21205, 21212, 21298, 21513, 21906, 21939, 22328, 32244, 32348, 32355, 32375, 22051, 22298, 30145, 32412, 32690, 33218, 33635, 33061, 8433, 18707, 30273, 32287, 32624, 33639, 32133, 21164, 32327, 33217, 10028, 21708, 13023, 21127, 21297, 33048, 72275, 32188, 32363, 32364, 32426, 22267, 22173, 32610, 32613, 32799, 32859, 32654, 39070, 21463, 32519, 33338, 10221, 20204, 39021, 22045; 3. Model Number (System): 782146 (1.5T) UDI-DI: 884838108691; Serial Numbers: 32679, 33002, 33480, 33570, 30308, 33611, 32251, 22251, 13013, 21990, 32407, 32683, 8935, 20414, 32116; 4. Model Number (System): 782145 (3.0T) UDI-DI: 884838108684; Serial Numbers: 34256, 38295, 74041, 34144, 17377, 38127, 38313, 73004, 23029, 24062, 34208, 17435, 38276; 5. Model Number (System): 781270 (XR and 3.0T) UDI-DI: 884838095083; Serial Numbers: 17536, 17212, 17508, 24013, 38184, 23011, 17290, 34060, 38366, 17434, 38013, 38109, 17302, 17429, 17006, 17378, 17386, 35073, 38062, 17533, 17590, 34111, 38235, 17204, 17292, 17339, 17415, 17416, 17436, 17447, 23030, 24055, 34032, 34142, 34145, 34152, 34211, 35044, 38037, 38040, 38192, 38202, 38317, 17247, 17265, 17268, 17286, 17353, 17367, 17389, 17425, 17509, 17517, 17572, 17580, 24022, 24036, 34001, 34058, 35020, 35078, 38001, 38020, 38135, 38224, 17524, 23026, 24095, 34083, 34107, 34236, 34249, 35060, 17222, 17242, 17245, 17250, 17299, 17308, 17342, 17357, 17388, 17399, 17493, 17499, 17556, 17559, 17564, 17594, 23034, 24047, 24109, 24110, 24111, 24117, 24134, 34036, 34090, 34096, 34221, 35027, 35046, 35048, 35053, 38005, 38006, 38015, 38032, 38041, 38161, 38168, 17344, 17495, 17570, 17615, 24020, 24133, 34067, 34076, 34292, 38263, 17428, 23036, 38026, 38131, 38134, 17550, 24145, 38217, 38225, 17237, 34250, 38138, 17352, 17274, 34037, 34080, 35047, 38116, 17326, 17172, 17490, 24007, 38126, 17356, 38111, 24107, 38065, 38259, 38300, 38023, 38102, 74011, 17206, 17240, 17284, 17313, 17375, 17459, 17516, 24058, 24076, 34019, 34223, 35019, 35031, 35040; 6. Model Number (System): 782113 (XR and 3.0T) UDI-DI: 884838098909; Serial Numbers: 17449, 17455, 24154, 17470, 34059, 34262, 34056, 24052, 38106, 38066, 38082, 24097, 34172, 38049, 38070, 38142, 17238, 17372, 24135, 34143, 38354, 74036, 35070, 34072, 35041, 38105, 17271, 17346, 24021, 24093, 24146, 34117, 34127, 34128, 34129, 34153, 34202, 35045, 35059, 38094, 38290, 38311, 38310, 17560, 38114, 38166, 38261, 38042, 38281, 34110, 38117, 17521, 38010, 34130, 34304, 38219, 38222, 17307, 38075, 17384, 17461; 7. Model Number (System): 782129 (XR and 3.0T) UDI-DI: 884838105805; Serial Numbers: 34055, 38195; 8. Model Number (System): 782118 (Ingenia Elition X) UDI-DI: 884838099746; Serial Numbers: 71019, 71025, 42072, 42054, 42194, 85676, 42113, 42085, 42049, 42098, 42158, 42159, 85655, 85665; 9. Model Number (System): 782144 (Ingenia Elition X); UDI-DI: 884838108677; Serial Numbers: 71278, 42250, 71508, 71366;
Distribution: 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;
Voluntary or mandated: Voluntary: Firm initiated
Related 510(k)s: K110151 K193215 K213516 K213583 K230972 K251808
Location: Cambridge, MA, United States