{
  "meta": {
    "disclaimer": "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. We may limit or otherwise restrict your access to the API in line with our Terms of Service.",
    "terms": "https://open.fda.gov/terms/",
    "license": "https://open.fda.gov/license/",
    "last_updated": "2026-09-30",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "status": "Ongoing",
      "city": "Cambridge",
      "state": "MA",
      "country": "United States",
      "classification": "Class II",
      "openfda": {},
      "product_type": "Devices",
      "event_id": "99769",
      "recalling_firm": "Philips North America Llc",
      "address_1": "222 Jacobs St",
      "address_2": "",
      "postal_code": "02141-2289",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "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_number": "Z-3243-2026",
      "product_description": "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);",
      "product_quantity": "965",
      "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.",
      "recall_initiation_date": "20260821",
      "center_classification_date": "20260918",
      "report_date": "20260930",
      "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;",
      "more_code_info": ""
    }
  ]
}