{ "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": "2026-08-22", "results": { "skip": 0, "limit": 1, "total": 1 } }, "results": [ { "cfres_id": "210873", "product_res_number": "Z-0538-2025", "event_date_initiated": "2024-11-04", "event_date_posted": "2024-11-25", "recall_status": "Open, Classified", "res_event_number": "95645", "product_code": "MOS", "k_numbers": [ "K072873" ], "product_description": "dS Breast 16ch 3.0T", "code_info": "REF: 453530280731, 459801290741, 459801290741, 459801290744, 459801729891, 459801729892; UDI: 00884838065840, 00884838086197, 00884838098381, 00884838118041; Serial No. 538, 170, 437, 14, 124, 189, 291, 194, 516, 412, 154, 271, 536, 122, 190, 151, 1, 353, 577, 479, 446, 502, 522, 481, 583, 578, 608, 592, 160, 393, 421, 422, 438, 432, 540, 526, 470, 580, 477, 483, 586, 521, 133, 50, 440, 223, 461, 537, 517, 448, 550, 539, 573, 621, 628, 588, 152, 447, 389, 458, 498, 495, 141, 147, 609, 533, 400, 567, 505, 560, 391, 557, 371, 425, 442, 456, 459, 534, 582, 546, 584, 365, 367, 370, 360, 369, 317, 382, 394, 387, 407, 416, 441, 443, 462, 455, 467, 463, 468, 464, 515, 520, 504, 505, 574, 576, 547, 593, 594, 601, 595, 602, 599, 618, 134, 145, 137, 104, 48, 164, 253, 270, 193, 187, 242, 191, 252, 250, 278, 249, 316, 290, 302, 329, 372, 303, 269, 332, 333, 339, 314, 305, 364, 418, 428, 616, 27, 265, 381, 551, 615, 607, 128, 128, 390, 406, 554, 366, 413, 488, 499, 579, 174, 172, 165, 263, 500, 414, 544, 427, 549, 378, 460, 317, 445, 523, 552, 310, 311, 306, 449, 606, 424, 435, 524, 465, 466, 501, 530, 532, 546, 555, 541, 575, 566, 469, 588, 627, 590, 603, 340, 242, 375, 377, 388, 409, 434, 431, 444, 469, 509, 611, 127, 103, 158, 181, 318, 146, 358, 362, 357, 361, 506, 535, 619, 480, 523, 433, 361, 392, 401, 548, 571, 96, 123, 140, 296, 338, 313, 620, 380, 242, 439, 591, 383, 372, 558, 562, 600, 317, 356, 411, 426, 610, 173, 501, 396, 355, 379, 408, 410, 587, 612, 33, 47, 11, 124, 51, 135, 146, 36, 35, 105, 126, 143, 148, 159, 149, 150, 138, 162, 169, 176, 157, 218, 138, 294, 277, 363, 354, 335, 262, 373, 448, 15, 133, 107, 166, 20, 52, 22, 57, 67, 113, 112, 150, 156, 171, 168, 134, 172, 23, 24, 61, 93, 94, 19, 42, 74, 118, 155, 40, 116, 148, 140, 41, 100, 123, 127, 30, 10, 11, 38, 88, 21, 50, 66, 146, 71, 63, 28, 69, 59, 48, 75, 143, 126, 62, 125, 129, 122, 131, 9, 55, 54, 12, 157, 16, 101, 18, 60, 158, 58, 73, 68, 26, 31, 13, 17, 19, 34, 64, 65, 14, 175, 34, 119, 162, 130, 92, 95, 120, 46, 165, 159, 174, 167, 124, 176, 27, 90, 25, 89, 98, 114, 96, 70, 91, 132, 117, 49, 106, 121, 115, 29, 99, 154, 35, 15, 170, 83, 122, 10, 18, 12, 42, 13, 103, 39, 69, 114, 100, 61, 99, 76, 112, 117, 26, 72, 64, 108, 58, 175, 169, 179, 73, 67, 102, 106, 107, 139, 129, 86, 125, 174, 177, 52, 65, 101, 47, 57, 32, 82, 138, 77, 7, 84, 81, 75, 66, 22, 40, 28, 51, 30, 48, 29, 115, 46, 70, 60, 98, 45, 16, 79, 44, 43, 62, 56, 127, 31, 71, 55, 54, 126, 37, 111, 178, 128, 171, 78, 5, 6, 14, 19, 33, 49, 68, 3, 80, 38, 105, 123, 124, 173, 133, 121, 104, 135, 137, 132, 110, 11, 136, 131, 53, 50, 8, 24, 23, 41, 17, 74, 113, 97, 118, 134, 140, 176, 9, 20, 104, 120, 153, 79, 156, 184, 175, 71, 131, 145, 21, 23, 38, 22, 28, 40, 53, 43, 26, 45, 52, 2, 10, 27, 50, 44, 78, 9, 1, 47, 64, 73, 63, 76, 82, 49, 98, 140, 147, 166, 108, 107, 161, 39, 88, 95, 72, 83, 102, 134, 196, 214, 157, 146, 141, 143, 151, 228, 187, 125, 169, 159, 183, 186, 188, 195, 167, 182, 203, 222, 152, 202, 150, 208, 221, 211, 205, 178, 181, 201, 180, 199, 126, 90, 4, 46, 41, 30, 13, 16, 158, 162, 109, 8, 209, 67, 171, 193, 198, 54, 224, 226, 207, 135, 165, 174, 3, 7, 51, 81, 34, 25, 32, 33, 56, 192, 142, 144, 130, 80, 154, 155, 177, 215, 227, 223, 225, 210, 216, 217, 60, 160, 57, 149, 89, 173, 137, 179, 31, 59, 86, 93, 29, 68, 61, 124, 105, 103, 200, 194, 168, 204, 212, 206, 170, 189, 69, 218, 129, 37, 57, 95, 58, 62, 164, 128, 24, 42, 85, 122, 87, 100, 101, 99, 96, 138, 74, 97, 106, 65, 139, 219, 64, 38, 15, 14, 30, 17, 12, 20, 6, 8, 35, 56, 28, 29, 7, 72, 57, 3, 21, 1, 16, 75, 33, 58, 62, 22, 9, 25, 73, 31, 4, 5, 11, 67, 36, 37, 13, 34, 45, 23, 26, 66.", "firm_fei_number": "3016618143", "recalling_firm": "Philips North America Llc", "address_1": "222 Jacobs St", "city": "Cambridge", "state": "MA", "postal_code": "02141-2289", "additional_info_contact": "Customer Care Solution Center\n1-800-722-9377", "reason_for_recall": "Potential safety issue where a patient may be harmed while preparing for or during a scan.", "root_cause_description": "Use error", "action": "An URGENT MEDICAL DEVICE CORRECTION notice dated 10/31/24 was mailed to consignees. Consignees are to continue using affected systems in accordance with the intended use. When using the system follow section PRECAUTIONS, CAUTIONS & WARNINGS in the Instructions For Use (IFU). Consignees are to circulate the recall notice to all users for their awareness of the potential issue. The Recall Response Form is to be provided back to Philips MR within 30 days at Philips.Recall@philips.com. Customers with any questions are to contact their local Philips Representative.", "product_quantity": "5,231 units", "distribution_pattern": "US Nationwide distribution.", "openfda": { "k_number": [ "K113365", "K162863", "K023679", "K993776", "K171515", "K172695", "K183186", "K061950", "K093842", "K000589", "K971246", "K010946", "K213735", "K972340", "K002483", "K212864", "K222325", "K971016", "K070778", "K991765", "K071311", "K061281", "K163066", "K173290", "K973787", "K013810", "K113474", "K991113", "K001312", "K123492", "K011683", "K022487", "K013099", "K010513", "K982919", "K001946", "K052704", "K983139", "K172222", "K000345", "K033292", "K033490", "K223487", "K231647", "K061952", "K182737", "K062767", "K993235", "K013595", "K083160", "K983109", "K000002", "K100141", "K223239", "K081322", "K072931", "K032633", "K262294", "K052827", "K090267", "K113280", "K973630", "K112293", "K103335", "K051763", "K093284", "K033152", "K070629", "K053042", "K011781", "K964668", "K050307", 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