{ "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": "2026-08-13", "results": { "skip": 0, "limit": 1, "total": 1 } }, "results": [ { "cfres_id": "210586", "product_res_number": "Z-0321-2025", "event_date_initiated": "2024-10-11", "event_date_posted": "2024-11-07", "recall_status": "Open, Classified", "res_event_number": "95559", "product_code": "DPS", "k_numbers": [ "K152944" ], "product_description": "Hillrom Welch Allyn Q-Stress Cardiac Stress Testing System; cardiac stress test", "code_info": "Software Versions: \nSoftware Version V6.0.0 V6.3.2, Release Date 02-Jul-2015\nUnits: \n1) UDI/DI 00732094263213, Serial Numbers: 117240573990, 117360584950; \n\n2) UDI/DI 00732094263237, Serial Numbers: 117500600524, 122410000834; \n\n3) UDI/DI 00732094263336, Serial Numbers: 118110620686; \n\n4) UDI/DI 00732094263374, Serial Numbers: 116520545398, 116520545399, 117050553501, 117050553502, 117170565092, 117170565093, 117170565094, 117170565095, 117170565096, 118090616242, 118090616243, 118170632609, 118170632608, 118100617936, 118100617935, 118100617934, 118340000113, 118340000114, 118340000115, 118340000116, 118340000117, 118340000118, 118340000119, 118450001233, 118450001234, 118450001235, 118450001236, 118450001237, 118450001238, 118450001239, 118450001240, 118450001241, 119330000811, 119330000812, 119330000813, 119330000814, 119330000815, 119330000816, 119330000817, 119330000818, 119330000819, 119330000820, 119330000821, 120010000185, 120010000186, 120010000187, 120010000188, 120010000189, 120110000599, 120110000600, 120110000601, 120110000602, 120110000603, 121050000579, 121050000580, 121410001265, 121410001266, 121410001267, 121410001268, 122460001565, 122460001566, 122460001567, 123370000157, 123370000158; \n\n5) UDI/DI 00732094263381, Serial Numbers: 116160400812, 116160400841, 116160400843, 116160400845, 116400529512, 116400529513, 116400530030, 116400530031, 116400530032, 116450536621, 116450536622; \n\n6) UDI/DI 00732094263398, Serial Numbers: 118110620685, 118210639085; \n\n7) UDI/DI 00732094263411, Serial Numbers: 117290578773; \n\n8) UDI/DI 00732094263428, Serial Numbers: 116120375032, 116120375035, 117060553847, 117120556934, 117120556935, 120330000900, 120360000449, 122360000839, 122490000191, 122490000192; \n\n9) UDI/DI 00732094263435, Serial Numbers: 117310581163; \n\n10) UDI/DI 00732094263626, Serial Numbers: 116170410170; \n\n11) UDI/DI 00732094263671, Serial Numbers: 120050000514; \n\n12) UDI/DI 00732094263879, Serial Numbers: 116500544081, 116500544082, 116500544083, 117050553074, 117050553075, 117050553076, 117380587626, 117380587627, 117460595385, 117460595386, 117460595387, 117460595388, 117460595389, 117460595390, 118090616424, 118090616425, 118090616426, 118170632607, 118170632606, 118100617938, 118100617937, 118460000409, 118460000410, 118460000411, 118460000412, 118460000413, 118460000414, 121050000574, 121050000575, 121050000576, 121050000577, 121050000578, 121110000824, 121110000825, 121110000826, 121110000827, 121110000828, 121110000829, 121110000830, 121110000831, 121110000832, 121110000833, 121110000834, 121110000835, 121110000836, 121170000411, 121170000412, 121170000413, 121170000414, 121170000415, 121170000416, 121170000417, 121240001237, 121240001238, 121370000463, 121370000464, 121370000465, 121370000466, 121370000467, 121410001255, 121410001256, 121410001257, 121410001258, 121410001259, 121410001260, 121410001261, 121410001262, 121410001263, 121410001264, 122460001573, 122460001574, 122460001575, 122460001576, 122460001577, 123030001336, 123030001337, 123030001338, 123030001339, 123030001340, 123030001341, 123030001342, 123030001343, 123030001344, 123030001345, 123030001346, 123030001347, 123200001027, 123200001028, 123200001029, 123200001030, 123200001031, 123200001032, 123250001021, 123250001022, 123250001023, 123250001024, 123250001025, 123250001026, 123280000365, 123280000366, 123280000367, 123280000368, 123280000369, 123280000370, 123370000153, 123370000154, 123370000155, 123370000156, 123480000934, 123480000935, 123480000936, 121370000466, 124110000985, 124160001082, 124160001083, 124160002095, 124160002096, 124160002097, 124160002098, 124160002099, 124160002100, 124160002101, 124160002102, 124160002103, 124160002104, 124160002105, 124160002106, 124160002107, 124160002108, 124160002109, 124160002110, 124160002111, 124160002112, 124160002113, 124160002114; \n\n13) UDI/DI 00732094263893, Serial Numbers: 118070613221, 120390000393, 122240001151; \n\n14) UDI/DI 00732094263930, Serial Numbers: 116150390528; \n\n15) UDI/DI 00732094263947, Serial Numbers: 115510284680, 115510284694, 119240000738; \n\n16) UDI/DI 00732094289169, Serial Numbers: 118290001244, 118460002309, 118480000818; \n\n17) UDI/DI 00732094296273, Serial Numbers: 118380000431; \n\n18) UDI/DI 00732094308426, Serial Numbers: 122480001104, 123270000832; \n\n19) UDI/DI 00732094309645, Serial Numbers: 119080001407, 119080001408; \n\n20) UDI/DI 00732094312898, Serial Numbers: 119470002281, 119470002281; \n\n21) UDI/DI 00732094312904, Serial Numbers: 121400000049, 121400000050, 121400000051; \n\n22) UDI/DI 00732094312928, Serial Numbers: 122360000843, 122370001541, 122370001542, 123460001117, 123460001118, 123430001428, 123430001429, 123460001117; \n\n23) UDI/DI 00732094312942, Serial Numbers: 120030000547, 120030000548, 120180000461, 120180000462, 120180000463, 120180000464, 120180000465, 120180000466, 120180000467, 120180000468, 120180000463; \n\n24) UDI/DI 00732094312966, Serial Numbers: 119100000503, 119350002685; \n\n25) UDI/DI 00732094315660, Serial Numbers: 119140000184, 119270000109, 119270000110, 120110000692, 120110000693, 120300000079, 121340000884; \n \n26) UDI/DI 00732094318029, Serial Numbers: 123130002242, 123480000937, 123480000937, 124240000223; \n\n27) UDI/DI 00732094318432, Serial Numbers: 120050000646, 120050000647, 120050000648, 120050000649, 120050000650; \n\n28) UDI/DI 00732094321029, Serial Numbers: 119260000098; \n\n29) UDI/DI 00732094323726, Serial Numbers: 119320000899; \n\n30) UDI/DI 00732094326604, Serial Numbers: 119470001903; \n\n31) UDI/DI 00732094336054, Serial Numbers: 120210000789, 121400000901, 121400000902, 122190000640, 122190000641, 122350000278, 122350000279, 123170000266, 123260000923, 123260000924, 10073209433605400, 124110000987, 124250000729; \n\n32) UDI/DI 00732094336061, Serial Numbers: 120210000797, 120210000798, 120210000792, 120210000791, 120210000795, 122290000259, 122290000260, 122290000261, 122290000262, 122380000700, 122380000701, 122460000204, 122460000205, 122460000206, 122500001005, 123270000162, 123270000163, 123270000164, 123270000165, 123280001082, 123490000968, 123490000969, 123500002175, 124200000067, 124200000068, 124200000069; \n\n33) UDI/DI 00732094343786, Serial Numbers: 120520000671, 120520000672, 120520000673, 120520000674, 120520000675, 120520000676, 120520000677, 121040000860, 121040000861, 121040000862, 121040000863, 121040000864, 121040000865, 121040000866, 121040000867, 121040000868, 121040000869, 121040000870, 121040000871, 121040000872, 121040000873, 121040000874, 121040000875, 121040000876, 121040000877, 121040000878, 121040000879, 121050000573, 122020001206, 122020001207, 122020001208, 122020001209, 122020001210, 122020001211, 123280000372, 0, 122020001206, 124100001853, 124100001854, 124100001855, 124220001281, 124280000769; \n\n34) UDI/DI 00732094352672, Serial Numbers: 122310001547; \n\n35) UDI/DI 00812345027563, Serial Numbers: 116070311290, 116070311292, 116070311294, 116100332892, 116130382051, 116130376108, 116140389082, 116140388756, 116170410169, 116180416553, 116180416555, 116190431282, 116210444330, 116230450214, 116230450216, 116240477304, 116240477860, 116240477862, 116240477864, 116240477867, 116240477869, 116240477871, 116230455570, 116230455572, 116230455574, 116230455576, 116230455578, 116230455580, 116230455582, 116230455584, 116230455588, 116310520897, 116310520898, 116230455586, 116310520896, 116320521690, 116320521865, 116330522902, 116330522848, 116330522849, 116340523648, 116350524130, 116370526975, 116400529514, 116400529515, 116400529516, 116400529517, 116400529518, 116390529090, 116370526974, 116400529519, 116400529520, 116400529521, 116400529522, 116400529523, 116400529920, 116400529921, 116400530088, 116400530553, 116400530028, 116420531722, 116420532142, 116430534054, 116430534055, 116450536077, 116450536208, 116460537576, 116460538355, 116460537453, 116470539394, 116490542247, 116490542248, 116510544247, 116510545330, 116510545331, 116520546402, 116520546401, 116520546230, 116520546403, 116520546400, 117050553073, 117060553950, 117080555092, 117090555749, 117090555843, 117090555865, 117090555866, 117090555867, 117110556362, 117110556363, 117110556289, 117110556290, 117120556937, 117120557454, 117120557458, 117120557459, 117120557460, 117130560125, 117130560428, 117130560970, 117140562012, 117150562725, 117140562010, 117140562011, 117150562893, 117160564733, 117170565765, 118210000029, 118210000030, 117200568387, 117200568404, 117190568245, 117190568246, 117190568247, 117190568248, 117190568249, 117200568664, 117200568665, 117200568666, 117210570494, 117220571853, 117220571854, 117220571855, 117220571856, 117240573477, 117250575043, 117250574851, 117260576250, 117290578774, 117290579353, 117300579812, 117300579810, 117320581838, 117310581538, 117330582979, 117350583853, 117350583854, 117340583699, 117350583855, 117340583702, 117350584009, 117350584025, 117350584041, 117350584042, 117350584043, 117360584752, 117360585080, 117370585583, 117380586304, 117380586303, 117380587697, 117380587478, 117380587698, 117410589631, 117400589312, 117410589632, 117410589633, 117430591573, 117440593332, 117440593333, 117440593334, 117440593335, 117440593336, 117440593337, 117430592467, 117430592468, 117470596323, 117470596320, 117470596321, 117470596322, 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118340000908, 118350000117, 118350000118, 118360000051, 118360000052, 118360000053, 118360000054, 118360000055, 118360000056, 118360000057, 118360000058, 118360000059, 118360000518, 118360000519, 118360000520, 118360000521, 118360000522, 118360000523, 118360000524, 118360000525, 118380001931, 118380001932, 118390000386, 118390000387, 118390000388, 118390000389, 118390000390, 118400000207, 118400000208, 118400000209, 118400000210, 118400000211, 118400000698, 118400000699, 118400000700, 118430001304, 118430001305, 118430001306, 118450001177, 118460001582, 118460001583, 118470000260, 118470000261, 118500000639, 118500000640, 118500000641, 118500000642, 118500000643, 118520000905, 119040000854, 119050000681, 119050000682, 119050000683, 119050000684, 119060001359, 119060001360, 119070000214, 119070000215, 119070000216, 119080000186, 119080000187, 119080000188, 119080000189, 119110000756, 119120001149, 119120001150, 119120001151, 119120001152, 119160000318, 119160000319, 119170000425, 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121430000254, 121430000255, 121430000256, 121430000257, 121430000258, 121440000127, 121440000129, 121440000130, 121450000055, 121450000056, 121450000057, 121450000058, 121450000272, 121450000273, 121450000274, 121450000275, 121450000276, 121450000277, 121450000278, 121450000279, 121460001256, 121460001257, 121480000746, 121480000747, 121480000748, 121480000749, 121480000750, 121480000751, 121480000752, 121490000354, 121490000355, 121490000356, 121490000357, 121500000277, 121500000278, 121500000279, 121500000280, 121500000281, 121500000282, 121500000283, 121500000284, 121500000285, 121500000286, 121510000627, 121510000628, 121510000629, 121510000630, 121510000631, 121510000632, 121510000633, 121510001476, 121510001477, 121520001601, 121520001602, 121520001603, 121520001604, 121520001605, 121520001606, 122010001000, 122010001001, 122010001002, 122020001893, 122020001894, 122020001895, 122020001896, 122020001897, 122020001898, 122020001899, 122050000144, 122050000145, 122050000146, 122050000147, 122050000148, 122050001250, 122050001251, 122060001853, 122060001854, 122060001855, 122060001856, 122060002364, 122060002365, 122060002366, 122060002367, 122070001243, 122070001244, 122070001245, 122070001246, 122070001247, 122070001248, 122080000271, 122080000272, 122080000273, 122080000274, 122090001806, 122090001807, 122090001808, 122090001809, 122100000099, 122100000100, 122100000101, 122100000102, 122100001652, 122100001653, 122100001654, 122100001655, 122120000186, 122120000187, 122120000188, 122120000189, 122120002581, 122120002582, 1, 2, 122140000065, 122140000066, 122140000067, 122140000403, 122140000404, 122140000405, 122140001072, 122140001073, 122140001074, 122150001600, 122150001601, 122150001602, 122150001603, 122160000164, 122160000165, 122160000166, 122160000167, 122160000168, 122160001940, 122160001941, 122160001942, 122180000445, 122180000446, 122180000447, 122180000448, 122180000449, 122180000450, 122180000451, 122180001855, 122180001856, 122180001857, 122180001858, 122190000633, 122190000634, 122190000635, 122190000636, 122190000637, 122190000638, 122190000639, 122250000632, 122250000633, 122250000634, 122250000635, 122250000636, 122250000637, 122250000638, 122250000639, 122250000640, 122250000641, 122250000642, 122250000643, 122250000644, 122250000645, 122250000646, 122250000647, 122260000877, 122260000878, 122260000879, 122260000880, 122260000881, 122260000882, 122260000883, 122260000884, 122270001022, 122270001023, 122270001024, 122270001025, 122270001026, 122270001027, 122270001028, 122270001029, 122300000989, 122300000990, 122300000991, 122300000992, 122300000993, 122300000994, 122300000995, 122300000996, 122300000997, 122300000998, 122300000999, 122300001000, 122300001001, 122300001002, 122320000948, 122320000949, 122320000950, 122320000951, 122320000952, 122320000953, 122350000756, 122350000757, 122350000758, 122360000825, 122360000826, 122360000827, 122360000828, 122360000829, 122360000830, 122360000833, 122360000834, 122360000835, 122360000836, 122360000837, 122360001380, 122360001381, 122360001382, 122360001383, 122370001098, 122370001099, 122370001100, 122370001101, 122370001102, 122380002039, 122380002040, 122400000631, 122400000632, 122400000633, 122400000634, 122410001215, 122410001216, 122410001217, 122410001218, 122420000369, 122420000370, 122420000371, 122420000372, 122420000373, 122430000180, 122430000181, 122430000182, 122440000137, 122440000138, 122440000139, 122440000140, 122450002102, 122450002103, 122450002104, 122450002105, 122450002106, 122470000666, 122470000667, 122470000668, 122470000669, 122470000670, 122470000671, 122490000186, 122490000187, 122490000188, 122490000189, 122490000190, 122500000998, 122500000999, 122500001000, 122500001001, 122500001865, 122500001866, 122500001867, 122500001868, 122510000168, 122510000169, 122510000170, 122510000171, 122510000172, 122510001102, 122510001103, 122510001104, 122510001105, 122510001106, 122510001107, 122510001108, 122510001109, 123010001118, 123010001119, 123010001120, 123010001121, 10081234502756300, 123030001329, 123030001330, 123030001331, 123030001332, 123040001923, 123040001924, 123040001925, 123040001926, 123040001927, 123040001928, 123060000567, 123060000568, 123060000569, 123070001941, 123070001942, 123070001943, 123070001944, 123070001945, 123070001946, 123070001947, 123070001948, 123090001292, 123090001293, 123100001464, 123100001465, 123100001466, 123110000409, 123110000410, 123110000411, 123110000412, 123130000027, 123130000028, 123130000029, 123130001278, 123130001279, 123140000705, 123140000706, 123140000707, 123140000750, 123140000751, 123140000752, 123140000753, 123140000754, 123140001384, 123140001385, 123140001386, 123140001387, 123150001149, 123150001150, 123230000930, 123230000931, 123230000932, 123230000933, 123230000934, 123240001033, 123240001034, 123240001035, 123240001036, 123240001037, 123250000709, 123250000710, 123250000711, 123250000712, 123250000713, 123250000788, 123250000789, 123250000790, 123250000791, 123250000792, 123270000268, 123270000269, 123270000270, 123270000271, 123270000272, 123270000273, 123270000274, 123270000275, 123270000276, 123270000277, 123270000278, 123280000407, 123280000408, 123280000409, 123290000577, 123290000578, 123290000579, 123300001483, 123300001484, 123300001485, 123310000824, 123310000825, 123310001371, 123310001372, 123310001373, 123330000139, 123330000140, 123380001327, 123380001328, 123380001329, 123380001330, 123380001331, 123380001332, 123380001333, 123410000813, 123490000428, 123490000429, 123490000526, 123490000527, 123490000528, 123490000529, 123490000953, 123490000954, 123490000955, 123490000956, 123490000957, 123500000555, 123500000556, 123500000557, 123500000558, 123500000559, 123500002161, 123500002162, 123500002163, 123500002164, 123500002165, 123500002166, 123500002167, 123500002168, 123500002169, 123510000031, 123510000032, 123510000033, 123510000034, 123510000035, 123510000131, 123510000132, 123510000133, 123510000134, 123510000301, 123510000302, 123510000313, 123510000314, 123510000315, 123510000316, 123510000317, 123510000318, 123510000319, 123510000320, 123510000321, 123510000322, 123520000796, 123520000797, 123520000798, 123520000799, 124010000285, 124010000286, 124010000287, 124010000288, 124030000217, 124030000218, 124030000693, 124040001762, 124040001763, 124050000676, 124050000677, 124050000678, 124050001230, 124050001231, 124080000859, 124080000860, 124090000928, 124090000929, 124090001302, 116400529519, 117110556362, 117120556937, 117330582979, 117440593332, 117440593333, 117440593334, 117440593335, 117440593336, 117440593337, 118270000715, 119230002429, 119380001359, 119400000248, 119510001186, 120100001904, 120530000551, 121030000259, 121180000763, 121180000764, 121320001531, 121420000475, 121520001604, 122100000101, 122180000445, 122180000446, 122180000447, 122260000877, 122320000951, 123140000750, 123240001033, 123270000268, 123270000269, 123520000796, 124050001231, 124080000859, 124080000860, 124090000928, 124090000929, 124090001302, 124090001303, 124090001304, 124100001851, 124100001852, 124110001353, 124110001354, 124120000001, 124120000002, 124130001408, 124130001409, 124140000399, 124140000400, 124150000013, 124150000014, 124160001084, 124160001085, 124160001086, 124160001087, 124160001088, 124170000662, 124170000663, 124170001412, 124170001413, 124180001023, 124180001024, 124180001025, 124180001026, 124190000585, 124190000586, 124190000587, 124190000588, 124200000064, 124200000065, 124200000066, 124220001276, 124220001277, 124220001278, 124230001162, 124230001163, 124230001164, 124240000767, 124240000768, 124240000769, 124240000770, 124250001193, 124250001194, 124260000411, 124260000412, 124260000413, 124260000415, 124260000416, 124260000417, 124260000771, 124260000772, 124260000773, 124260000774; \n\n36) UDI/DI 00812345027570, Serial Numbers: 116070306098, 116070307281, 116070311291, 116110360656, 116110360658, 116110360660, 116190428764, 116190431265, 116190431268, 116190431239, 116190431241, 116210440023, 116220447275, 116250485174, 116250485959, 116260491968, 116260491970, 116260491972, 116260491974, 116280504761, 116280504768, 116290516786, 116290516812, 116290516813, 116290516815, 116280506964, 116280506966, 116300519873, 116320522168, 116330523070, 116340523725, 116340523726, 116340523727, 116340523728, 116350524962, 116370526231, 116370526235, 116380527225, 116380528397, 116380528398, 116380528399, 116380528400, 116390529085, 116390529086, 116390529087, 116400530261, 116410531492, 116410531499, 116420532365, 116440535274, 116440535550, 116450536751, 116460537578, 116460537579, 116490541737, 116460537577, 116500542854, 116500542855, 116500543269, 116510545083, 116530546706, 116530547125, 116530546705, 116530547310, 116530547262, 116530547263, 117010549347, 117010549348, 117010549349, 117030551222, 117030551223, 117030551224, 117030551198, 117060553621, 117080554650, 117090555978, 117120556692, 117120556693, 117120556669, 117120556938, 117120556939, 117110556361, 117130560356, 117130559722, 117130559723, 117130559724, 117130559725, 117130560366, 117130560907, 117130560908, 117130560909, 117130559206, 117130559207, 117140562692, 117140561999, 117140562000, 117180567011, 117200568668, 117200568669, 117200569177, 117210570093, 117210570094, 117210570095, 117210570736, 117230572508, 117230572509, 117230572795, 117230572796, 117230572797, 117240573777, 117250575370, 117260576146, 117260576380, 117260576147, 117260576521, 117260576907, 117270577366, 117270577367, 117270577369, 117300580355, 117260576919, 117330582978, 117340583701, 117340583700, 117340583703, 117350584566, 117360584806, 117380586443, 117380586438, 117380586439, 117380586440, 117380587063, 117390588206, 117410590220, 117420591116, 117460595235, 117480597799, 117490599957, 117490599958, 117490599959, 117500601066, 117480597585, 117490599960, 117510602015, 117510602783, 118010604423, 118030607407, 118030607409, 118050609952, 118090615612, 118090616239, 118190635182, 118180633951, 118150626794, 118110620676, 118110620675, 118030607408, 118110620673, 118110620672, 118110620671, 118110620670, 118120622027, 118110620674, 116520545400, 116520545401, 118200637266, 118200637265, 118200637264, 118190635507, 118190635506, 118190635505, 118190636600, 118190636599, 118210638582, 118210638581, 118240001206, 118250002189, 118250002190, 118260000335, 118260000336, 118260000337, 118260000338, 118260000339, 118260000340, 118260000341, 118260000342, 118260000343, 118270000716, 118270000717, 118300001211, 118300001212, 118310000439, 118310000440, 118310001698, 118340000909, 118340000910, 118340000911, 118350000119, 118350000120, 118350000895, 118360000412, 118370000771, 118370000772, 118370001923, 118390000401, 118400000212, 118400000213, 118420000444, 118420000445, 118450000914, 118450000915, 118460002307, 118480000811, 118480000812, 118480000813, 118490000215, 118490000216, 118520000469, 119030000098, 119060000834, 119070000043, 119090001179, 119100000457, 119120000287, 119120001590, 119120001591, 119160000320, 119190000655, 119220000831, 119230002432, 119230002433, 119240000162, 119240000163, 119240000739, 119250000556, 119250000557, 119250000558, 119260000972, 119260000973, 119260000974, 119260000975, 119260000976, 119260000977, 119260001787, 119260001788, 119260001789, 119270000453, 119280000608, 119280000609, 119290000534, 119290000601, 119300000175, 119330000158, 119330000159, 119330000810, 119350002908, 119350002909, 119380001374, 116300519874, 116300519875, 116300519876, 119420001080, 119420001081, 119420001082, 119420001083, 119460000136, 119460000137, 119460000138, 119460001074, 119460001075, 119470000521, 119470000522, 119470001904, 119470001905, 119470001906, 119480000259, 119480000260, 180, 119500001102, 119500001103, 119500001104, 119520000619, 119520000620, 120020001162, 120050000516, 120060000648, 120070001212, 120070001213, 120070001214, 120070001215, 120070001216, 120070001217, 120080002241, 120080002242, 120110001828, 120110001829, 120110001830, 120130000348, 120130000349, 120130001386, 120130001387, 120140001041, 120140001042, 120140001043, 120140002514, 120140002515, 120160001500, 120160001501, 120160001502, 120160001503, 120160001504, 120160001505, 120180001098, 120180001099, 120180001100, 120180001101, 120310001596, 120310001597, 120310001598, 120360001242, 120360001243, 120360001244, 120360001245, 120380000309, 120380000310, 120390000394, 120390001597, 120390001598, 120400001334, 120400001335, 120410000592, 120410001054, 120410001292, 120410001293, 120410001294, 120410001295, 120410001296, 120450000602, 120460000684, 120460000685, 120460000686, 120460002793, 120460002794, 120470000599, 120480000005, 120480000006, 120480000007, 120490001517, 120490001518, 120490001519, 120490001520, 120490001521, 120490001522, 120490001523, 120490001524, 120490003111, 121030000755, 121030000756, 121070000464, 121070002513, 121070002514, 121090001937, 121090001938, 121090001939, 121090001940, 121120000018, 121120000019, 121120000020, 121120000021, 121120000022, 121140000280, 121140000281, 121140000282, 121160001418, 121160001419, 121190000939, 121200000017, 121200000018, 121230000160, 121230000161, 121230002023, 121240000675, 121240000676, 121240000677, 121300001874, 121310001142, 12130001679, 121330001320, 121360001298, 121360001299, 121360001300, 121360001301, 121360001302, 121390002096, 121390002097, 121390002098, 121400000055, 121400001921, 121400001922, 121400001923, 121420000476, 121430000259, 121450000280, 121450001401, 121460001164, 121480000753, 121480000754, 121500000287, 121500000288, 121500000289, 121500000290, 121500000291, 121500000292, 121510001474, 121510001475, 121520000976, 121520000977, 121520000978, 121520000979, 121520000980, 121520000981, 121520001607, 121520001608, 122010001005, 122010001006, 122010001007, 122010001008, 122020000513, 122020001900, 122020001901, 122020001902, 122020001903, 122040000642, 122040000643, 122050001244, 122050001245, 122050001246, 122050001247, 122070001238, 122070001239, 122070001240, 122070001241, 122070001242, 122250000648, 122250000649, 122250000650, 122250000651, 122250000652, 122250000653, 122250000654, 122250000655, 122250000656, 122260000886, 122290001134, 122290001135, 122290001136, 122290001137, 122290001138, 122310001545, 122310001546, 122320000462, 122350000276, 122350000277, 122360000423, 122360000424, 122370000068, 122370000069, 122370000070, 122430000183, 122450000618, 122450000619, 122480002103, 122480002104, 122480002105, 122480002106, 122490000194, 122490000195, 122490000196, 122490000197, 122490000198, 122490000199, 122500001002, 122500001003, 122500001004, 122510000167, 123010000259, 123010000260, 123010000261, 123010000262, 123010000263, 123030001333, 123030001334, 123030001335, 123050001345, 123050001346, 123050001347, 123050001348, 123070000719, 123090001294, 123100001960, 123100001961, 123100001962, 123100001963, 123100001964, 123170000267, 123180000488, 123180000489, 123210000350, 123210000351, 123250000059, 123250000060, 123250000061, 123250000062, 123250000063, 123250000064, 123250001027, 123260000226, 123270000161, 123270001064, 123270001065, 123270001066, 123270001067, 123270001068, 123270001069, 123270001070, 123270001071, 123280000373, 123280000374, 123280000375, 123290000582, 123290000583, 123290000584, 123300001832, 123300001833, 123300001834, 123310001376, 123310001377, 123310001378, 123330000777, 123330000778, 123330000779, 123350000286, 123350000287, 123350000288, 123350000289, 123380001337, 123380001338, 123410000814, 123430001155, 123430001156, 123430001157, 123430001158, 123430001159, 123430001160, 123430001161, 123430001162, 123490000430, 123490000431, 123490000432, 123490000530, 123490000531, 123490000532, 123490000533, 123490000534, 123490000535, 123490000958, 123490000959, 124010000665, 124010000666, 124010000667, 124010000936, 124020000038, 124020000039, 124040001495, 124040001496, 116420532365, 116530547310, 117120556938, 117120556939, 117240573777, 118210638582, 119260000973, 119470000522, 120180001098, 122070001239, 122260000886, 122360000424, 123430001162, 124040001497, 124040001498, 124040001499, 124150000015, 124160001089, 124170001411, 124180000264, 124220001279, 124220001280, 124240000771, 124240000772, 124240000773, 124240000774, 124240000775, 124240000776, 124240000777, 124240000778, 124240000779, 124240000780, 124250001192, 124260000414, 124280000121, 124280000122, 124280000123, 124280000124, 124310000674, 124310000675, 124310000676, 124310001824, 124310001825, 124310001826, 124310001827, 124320000664, 124320000665, 124320000666; \n\n37) UDI/DI 00812345027587, Serial Numbers: 116120372696; \n\n38) UDI/DI 00812345027594, Serial Numbers: 116130383210, 116200436395, 116200436397, 116200436399, 116200436401, 116210442885, 116210442887, 116210442889, 116210442891, 116240457675, 117200568392, 117200568393, 117250574849, 117250574850, 117320582072, 117510602786, 118330000152, 118350000588, 118350000589, 118380001933, 118380001934, 118380001935, 118380001936, 118380001937, 118380001938, 118380001939, 119390000706, 119390000707, 119390000708, 119390000709, 119390000710, 119470001908, 119470001909, 119470001910, 119470001911, 120050000574, 120050000575, 120050000576, 120050000577, 120050000578, 120050000579, 120050000640, 120050000641, 120050000642, 120050000643, 120050000644, 120050000645, 120090001347, 120090001348, 120090001349, 120100000627, 120100000628, 120100000629, 120110000195, 120110000196, 120110000197, 120110000198, 120110000199, 120120000639, 120120001444, 120120001445, 120120001446, 120120001447, 120220001019, 120220001020, 120320000362, 120320000363, 120330000290, 120400000334, 120400000335, 120400000336, 120400000337, 120400000338, 120400000339, 120400000340, 120400000341, 120400000342, 120400002605, 120400002606, 120400002607, 120400002608, 121070001281, 121090000176, 121090000177, 121090000178, 121090000179, 121120000015, 121140001536, 121330001321, 121330001322, 121330001323, 121330001324, 121370000468, 121400000047, 122040000384, 122260001674, 122260001675, 122370001543, 122440000911, 122490001735, 123490000960; \n\n39) UDI/DI 00812345027624, Serial Numbers: 116170411440, 116170411442; \n\n40) UDI/DI 00812345027723, Serial Numbers: 116210442893, 116280506968, 117370585104, 117520603131, 117520603629, 117520603132, 118110618488, 118110618489, 118190636540, 118180634599, 118110619531, 118110619529, 118110619530, 118320001194, 118340002364, 118340002365, 11838001950, 118500000657, 119100000504, 119240000466, 119250000167, 119310000759, 119390002491, 119390002492, 119460001342, 119480000721, 119500001540, 120030001174, 120310000229, 120360000152, 120500001270, 121040000709, 121050001720, 121050001721, 121080000529, 121130001982, 121180000664, 121240000844, 121290000691.121300001846, 121300001847, 121300001848, 121520000393, 121520000394, 122020001772, 122360000027, 122360000028, 122420000161, 123290000507, 10081234502772300, 123490001164, 123490001165, 123520001473, 124070000007, 10081234502772300, 116210442893, 117520603629, 124160000513, 124160000514, 124190000948, 124230000455, 124230000456; \n\n41) UDI/DI 00817655020754, Serial Numbers: 117020550574", "firm_fei_number": "1417572", "recalling_firm": "Baxter Healthcare Corporation", "address_1": "1 Baxter Pkwy", "city": "Deerfield", "state": "IL", "postal_code": "60015-4625", "additional_info_contact": "Center for One Baxter\n800-422-9837", "reason_for_recall": "There is the potential for exam files being assigned duplicate Unique Identifiers (UIDs),. If the system receiving the DICOM file (e.g., Picture Archiving and Communication System (PACS)) relies solely on the UID to accept exams, this could lead to a mismatch of the patients identification with their physiological data.", "root_cause_description": "Software design", "action": "Baxter issued an URGENT MEDICAL DEVICE CORRECTION notice to its consignees on 10/11/2024 via USPS First Class Mail. The notice explained the issue, potential hazard to the patient, and provided instructions for the to the system IT administrator to correct the issue which is already available in the current version of software.", "product_quantity": "2461 units", "distribution_pattern": "Worldwide distribution.", "openfda": { "k_number": [ "K241217", "K881939", "K251670", "K052511", "K072353", "K914206", "K896386", "K850021", "K950004", "K080036", "K051534", "K933065", "K853979", "K043074", "K914974", "K993875", "K030535", "K901817", "K171943", "K833458", "K771380", "K923221", "K922927", "K113485", "K862544", "K861992", "K973426", "K800492", "K032200", "K093339", "K791540", "K080884", "K133985", "K790114", "K852770", "K781054", "K180234", "K811016", "K800659", "K915879", "K880357", "K093872", "K760271", "K002473", "K790233", "K103077", "K090936", "K043380", "K081437", "K810357", "K813279", "K103427", "K020366", "K981951", "K171942", "K821758", "K844744", "K851643", "K913374", "K050858", "K904758", 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