Philips North America Llc: SmartPath to dStream for 1 recall

Recall details

FDA classification

Class II: use of or exposure to the product may cause temporary or medically reversible health problems, or the chance of serious problems is remote.

Status

Ongoing

Codes, lots and dates

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;

Quantity

965

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;

Recalling firm

Philips North America Llc, Cambridge, MA

Voluntary or mandated

Voluntary: Firm initiated

Recall started

2026-08-21