{ "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": "2026-08-20", "results": { "skip": 0, "limit": 1, "total": 1 } }, "results": [ { "cfres_id": "210594", "product_res_number": "Z-0325-2025", "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 XScribe Cardiac Stress Testing System; Programmable Diagnostic Computer", "code_info": "Software Versions: \nSoftware Version V6.0.0 V6.3.2, Release Date 02-Jul-2015\nUnits: \n1) UDI/DI 00732094259032, Serial Numbers: 115340269178, 117060553883, 117060553884, 117060553885, 119230003169; \n\n2) UDI/DI 00732094259070, Serial Numbers: 117130559202, 117130559203, 117130559204; \n\n3) UDI/DI 00732094259100, Serial Numbers: 116270497046, 117190567440; \n\n4) UDI/DI 00732094259148, Serial Numbers: 117350583961, 119060000843, 122090000529; \n\n5) UDI/DI 00732094259179, Serial Numbers: 116240458434, 116500543985, 120480000930; \n\n6) UDI/DI 00732094259230, Serial Numbers: 118160628177; \n\n7) UDI/DI 00732094259261, Serial Numbers: 117470596306; \n\n8) UDI/DI 00732094259285, Serial Numbers: 118100618358, 116110348774, 116490541753, 117430591185, 117510601740; \n\n9) UDI/DI 00732094259292, Serial Numbers: 116460537153, 118490000226; \n\n10) UDI/DI 00732094259308, Serial Numbers: 116120365527, 119410001349, 119410001350, 119410001351, 119410001352, 119410001353, 119410001354, 119410001355, 119410001356, 119410001357, 119410001358, 119410001359, 119410001360, 119410001361, 119410001362, 119410001363, 119410001364, 119410001365, 119410001366, 119410001367, 119410001368, 119410001369, 119410001370; \n\n11) UDI/DI 00732094259315, Serial Numbers: 117130559201; \n\n12) UDI/DI 00732094259322, Serial Numbers: 117350583998, 117500601523; \n\n13) UDI/DI 00732094259346, Serial Numbers: 116110347146, 116110347144; \n\n14) UDI/DI 00732094259445, Serial Numbers: 116430533831, 116430533832; \n\n15) UDI/DI 00732094259506, Serial Numbers: 116380527134, 117410589558, 118250001761, 119040000115, 119060000844, 119060000845, 123190000729, 123280000483, 123310000806, 123310000807, 123310000808, 123310000809, 123310000810, 123310000811, 123310000812, 123310000813, 123310000814, 123310000815, 123360000284, 123360000285, 123450001526, 123310000809, 123310000811, 123310000812, 123310000815; \n\n16) UDI/DI 00732094259575, Serial Numbers: 118250001384, 118260000794, 118390001821, 118480000848, 118480000849, 119060000841, 119060000842, 119090000727, 119100000033, 119150000332, 119240000238, 119240000239, 119240000240, 119250000166, 120010000573, 120290000988, 121400001929, 121430000537, 122050000996, 122090000520, 122090000521, 122090000522, 122090000523, 122090000524, 122090000525, 122090000526, 122090000527, 122090000528, 122170001299, 123250001020, 123340000589, 123520000414, 124060000807, 118480000848, 124060000807, 124170000873, 124170000874, 124170000875, 124170000876, 124170000877, 124170000878, 124170000879, 124170000880, 124170000881, 124170000882, 124280000135, 124280000136, 124280000137, 124280000138, 124280000139, 124320001530; \n\n17) UDI/DI 00732094259612, Serial Numbers: 116120365528; \n\n18) UDI/DI 00732094259650, Serial Numbers: 116240458430, 117220570917, 118120622072, 118170632918, 118180634236, 118300000863, 118330000273, 118330000274, 118420000151, 118440001977, 118480000847, 118520000564, 119170000630, 119270000360, 119270000361, 119270000362, 119350003349, 119380001118, 119380001119, 119430000811, 119340002163, 119470001921, 120050001766, 120050001767, 120050001768, 120130001344, 120140002540, 120180001090, 120180001094, 120220000883, 120320001828, 120330000906, 120380000317, 120450001959, 120450001960, 120450001961, 120450001962, 120460002493, 120460002494, 121070000871, 121130001178, 121150000446, 121190000645, 121200001260, 121200001261, 121230001203, 121230001205, 121280001926, 121290000365, 121290000366, 121370002519, 121370002520, 121370002521, 121370002522, 121370002523, 121370002524, 121380000290, 121380000291, 121380000292, 121380000293, 121380000294, 121380000295, 121380000296, 121380000297, 121380000298, 121380000299, 121380000300, 122020001217, 122020001218, 122020001219, 122020001220, 122020001221, 122020001222, 122070000778, 122070000779, 122070000780, 122070000781, 122080000291, 122120002598, 122120002599, 122120002600, 122140000214, 122220001051, 122250001505, 122470000642, 122470000643, 122470000644, 122470000645, 122470000646.122470000647, 122470000648, 122470000649, 122470000650, 122470000651, 123060000583, 123060000584, 123060000585, 123060000586, 123060000587, 123060000588, 123060000589, 123060000590, 123060000591, 123130000065, 123150000926, 123210000750, 123250001018, 123250001019, 123320000674, 123430000969, 124010000937, 124060000806, 120180001093, 121010002477, 123060000586, 123250001019, 123320000674, 123430000969, 124010000937, 124060000806, 124150000052, 124150000053, 124150000054, 124150000055, 124150000056, 124150000057, 124150000058, 124150000059, 124150000060, 124150000061, 124180000273, 124220000141, 124220000142; \n\n19) UDI/DI 00732094259681, Serial Numbers: 118520000552, 118520000554, 119470001920, 121060000078, 121370000332, 122100000410, 122130000800, 122220000669, 122220000670; \n\n20) UDI/DI 00732094259735, Serial Numbers: 118180635067, 118180635066, 118180635065; \n\n21) UDI/DI 00732094259766, Serial Numbers: 118190636601, 118190636602, 118190636603, 118190636604, 118190636605, 118480000844, 118480000845; \n \n22) UDI/DI 00732094259810, Serial Numbers: 118180635071, 118180635070, 118180635069, 118180635068, 119090000517, 119090000518, 122440001777, 124100001981, 124100001982; \n\n23) UDI/DI 00732094259889, Serial Numbers: 117390588078; \n\n24) UDI/DI 00732094259919, Serial Numbers: 116460538218, 116460538215, 116460538216, 116460538217; \n\n25) UDI/DI 00732094259971, Serial Numbers: 118130624172, 118130624171, 118130624170, 118130624169; \n\n26) UDI/DI 00732094260120, Serial Numbers: 116500544084, 119250000576, 120180001429; \n\n27) UDI/DI 00732094260137, Serial Numbers: 117380586599, 117380586600; \n\n28) UDI/DI 00732094260151, Serial Numbers: 117160563860, 117160563861, 117160563861; \n\n29) UDI/DI 00732094260199, Serial Numbers: 117510602780, 117510602781; \n\n30) UDI/DI 00732094260229, Serial Numbers: 116490541264, 116490541265, 117120557428, 117110556357, 117110556358, 117120557429, 119090000904, 119160000011, 121420001250, 121420001251, 121420001252, 122020000514, 122040000388, 122040000389, 122160000173, 122270001144, 122270001145, 122270001146, 122310000679, 122330000876, 122340000460, 122480000518, 123170000268; \n\n31) UDI/DI 00732094260267, Serial Numbers: 116470539357, 116470539358, 116470539359, 116470539360, 116470539361, 116470539362, 116470539363, 116470539364, 116470539365, 116470539366, 116470539367, 116470539368, 118140625738, 119020000217, 119020000218, 119020000219, 119130001319, 119130001320, 119130001321, 119460001369, 121320001536, 123240001506, 123240001507, 124200000349; \n\n32) UDI/DI 00732094260304, Serial Numbers: 117140562699, 117140562700; \n\n33) UDI/DI 00732094260342, Serial Numbers: 116510545162; \n\n34) UDI/DI 00732094260380, Serial Numbers: 116070308454, 116480540034, 118300000033, 118300000034, 118300000035, 118300000036, 118300000037, 118300000038, 118300000039, 118300000041, 118300000042, 118300000043, 118300000044, 118300000045, 118300000046, 118300000047, 118300000048, 118300000049, 118300000050, 118300000051, 118300000052, 118300000053, 118300000054, 118300000055, 118340000935, 118340000936, 118340000937, 118340000938, 118340000939, 118340000940, 118340000941, 118340000942, 118340000943, 118460001733, 118460001734, 119240000094, 120190001967, 120190001968, 120190001969, 120220001542, 120220001543, 120220001544, 120220001545, 120220001546, 122070001255, 118300000053, 118300000055, 120220001542; \n\n35) UDI/DI 00732094260434, Serial Numbers: 118300000860, 118460001730, 118460001732, 118480000841, 119130000112, 119130000113, 119130000114, 119200001280, 119200001614, 119380001489, 121150000434, 121150000435, 121360000218, 121450000733, 121520000986, 121520000987, 121520000988, 121520000989, 119380001489; \n\n36) UDI/DI 00732094260519, Serial Numbers: 113030149726, 113030149727, 118120623345, 114160206692, 115170254512, 115170254513, 117270576959, 118230000780, 118240001065, 118240001637, 118300000859, 118330001333, 118440000169, 118480000837, 119060000839, 119090000902, 119170000481, 119170000482, 119170000483, 119170000484, 119170000485, 119200000583, 119200001823, 119230002791, 119250000575, 119380001481, 119380001482, 119490000072, 119490000073, 120220000881, 120220000882, 120290000977, 120290000978, 120520000902, 121230000437, 121250001830, 122050000686, 122050000687, 122070000773, 122070000774, 122070000775, 122070000776, 122070000777, 120440001019, 120440001013, 122350000281, 122440001772, 122440001773, 122500001549, 122500001550, 123100001477, 123160001934, 123160001935, 123230001128, 123100001477, 123160001934, 123160001935, 123200001637, 123230001128, 124160002135, 124160002136, 124170000872, 124180000269, 124220001303, 124220001304; \n\n37) UDI/DI 00732094260533, Serial Numbers: 117390588115, 117390588116, 117390588117, 117390588118, 111130075526; \n\n38) UDI/DI 00732094260557, Serial Numbers: 114150206492, 114450235208, 117390588112, 117390588113, 117390588114, 118480000835, 119350003345, 121280001920, 121280001921, 122070001253, 122070001254, 122130000799, 122260000202, 122260000203, 122260000204, 122260000205, 122260000206, 122260000207, 122260000208, 123070001809, 123090001127, 123110000416, 123200001005, 123450001334, 123450001335, 114150206492, 123090001127, 123110000416, 123450001334, 123450001335, 124110001068, 124110001069, 124160000521; \n\n39) UDI/DI 00732094260601, Serial Numbers: 113480185300; \n\n40) UDI/DI 00732094260670, Serial Numbers: 118100617600, 113100154916, 118130624595, 118330000155, 118330000156, 118480000834, 119180000558, 119250001418, 119260000959, 120080000601, 120460002490, 121130001169, 121130001170, 122070001249, 122070001250, 122070001251, 122070001252, 122290000263, 122290000264, 122290000265, 122340000461, 122340000462; \n\n41) UDI/DI 00732094260731, Serial Numbers: 116120368670; \n\n42) UDI/DI 00732094260816, Serial Numbers: 113240166924, 117080554664, 117080554665, 117220571840, 118280000973, 118480000833; \n\n43) UDI/DI 00732094260847, Serial Numbers: 117520603150; \n\n44) UDI/DI 00732094260885, Serial Numbers: 116340523128, 116350524044. 117370586263; \n\n45) UDI/DI 00732094260892, Serial Numbers: 117380586444; \n\n46) UDI/DI 00732094260960, Serial Numbers: 117470596307, 118050609226; \n\n47) UDI/DI 00732094260991, Serial Numbers: 116500543942, 116500543943, 116500543944, 116500543945, 116500543946; \n\n48) UDI/DI 00732094261004, Serial Numbers: 116390529064; \n\n49) UDI/DI 00732094261028, Serial Numbers: 116460538216, 116460538217, 116110348790, 116070311448, 117370586263, 116070311445, 116070311446, 116070311447, 119380001488; \n\n50) UDI/DI 00732094261042, Serial Numbers: K16C001871, K16C001464, 118140625485, 118140625484, 118130623667, 118120623366, 118120623365, 118120623364, 118120623363, 118120623362, 118120623360, 118120623359, 118120623356, 118120623355, 118120623358, 118120623361, 118120623357, 118110619537, 118110619536, 118140625486, 118140625488, 118140625489, 118140625490, 118140625491, 118140625492, 118140625493, 119050000696, 119350003340, 119470002302, 119490000509, 21119350003340, 21119490000509, 119520000628, 120010000572, 120050001447, 21120010000572, 21120050001447, 121010000496, 118120623358; \n\n51) UDI/DI 00732094261196, Serial Numbers: 118270000496, 118270000497, 118270000498, 118310000442, 118310000443, 118310000444, 118310000445, 118310000446, 118310000447, 118460002316; \n\n52) UDI/DI 00732094294255, Serial Numbers: 118280001663, 118280001664, 118450000678, 118450000679, 118280001663; \n\n53) UDI/DI 00732094294538, Serial Numbers: 120140002538, 120140002539, 120320001826, 120320001827, 121060001018, 122220000671; \n\n54) UDI/DI 00732094294545, Serial Numbers: 122170001364; \n\n55) UDI/DI 00732094295429, Serial Numbers: 118360000421, 118370002214; \n\n56) UDI/DI 00732094296303, Serial Numbers: 119420001730, 119420001731, 119420001732, 119420001733, 119420001734, 119420001735, 119420001736, 121510000646, 121510000647, 121500000303, 123180000483, 123180000484; \n\n57) UDI/DI 00732094299908, Serial Numbers: 11810623357; \n\n58) UDI/DI 00732094299915, Serial Numbers: 118120623355, 118120623356, 118120623365, 118120623359, 118120623363; \n\n59) UDI/DI 00732094301472, Serial Numbers: 117500600621, 120440000589, 120440000590, 120440000591, 120440000592, 120440000593, 122440001762, 21120440000592, 12244001762, 122470000639; \n\n60) UDI/DI 00732094302974, Serial Numbers: 119020000643, 121320001539, 121320001540, 121320001541, 12341, 12342, 12343, 121420001245, 121420001246, 121420001247, 121420001248; \n\n61) UDI/DI 00732094316926, Serial Numbers: 119140001089, 119460000150, 119460000151; \n\n62) UDI/DI 00732094320176, Serial Numbers: 122360001053, ....; \n\n63) UDI/DI 00732094320183, Serial Numbers: 120110001003, 121050001860; \n\n64) UDI/DI 00732094332780, Serial Numbers: 117470596305, 120070001961, 120070001962, 120070001963, 120070001964, 120070001965, 120070001966, 120070001967, 120070001968, 120070001969, 120070001970, 120070001971, 120070001972, 120070001973, 120070001974, 120070001975, 120070001976, 120070001977, 120070001978, 120070001979, 120070001980, 120070001965, 120070001970, 120070001978; \n\n65) UDI/DI 00732094337518, Serial Numbers: 115350269606, 120270000572, 121470000326; \n\n66) UDI/DI 00732094338805, Serial Numbers: 114340225721; \n\n67) UDI/DI 00732094339444, Serial Numbers: 120400001336; \n\n68) UDI/DI 00812345027556, Serial Numbers: 116130382889, 116250489751, 116490541979, 117260576365, 118260000798, 118260000799, 117270577497, 117270577498, 118400001533, 118460001735, 119100000089, 119100000090, 120450001963, 120530000477, 121140001840, 121250000689, 121380000301, 121400001503, 121500001615, 121500001616, 122020001911, 122020001912, 122100000411, 122130000801, 122130000802, 122130000803, 122370001278, 122390000503, 122390000504, 122390000505, 122480002479, 122510000876, 123080000426, 123080000427, 123170000296, 123520001479, 123520001480, 124030000954, 123520001474, 121380000301, 124030000954, 124170000105, 124190001474; \n\n69) UDI/DI 00817655021997, Serial Numbers: 117370585639", "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": "766 units", "distribution_pattern": "Worldwide distribution.", "openfda": { "k_number": [ "K232035", "K850702", "K010758", "K760272", "K964784", "K832015", "K955642", "K822768", "K833951", "K101115", "K981807", "K002822", "K232161", "K082312", "K143432", "K230834", "K811016", "K142105", "K850323", "K961401", "K791364", "K903722", "K193415", "K031422", "K052295", "K143436", "K952173", "K233266", "K081437", "K150564", "K851633", "K874641", "K791420", "K844744", "K873584", "K131262", "K171517", "K800492", "K770832", "K014262", "K871993", "K820014", "K802718", "K883903", "K181998", "K852829", "K032200", "K050858", "K973437", "K761023", "K841611", "K800004", "K180242", "K083715", "K844392", "K810154", "K896417", "K183322", "K052898", "K103791", "K062282", "K051534", "K120770", "K221141", "K973426", "K791421", "K101403", "K820011", "K113234", "K180234", "K243252", "K163607", "K132068", "K200884", "K173830", "K042814", "K802952", "K770760", "K791201", "K903774", "K974220", "K171360", "K860212", "K885177", "K103640", "K062894", "K160876", "K852181", "K860790", "K883402", "K893660", "K072217", "K171942", "K082967", "K820067", "K170954", "K904355", "K113485", "K840869", "K120865", "K801677", "K930558", "K851643", "K110065", "K800659", "K232445", "K760271", "K030535", "K864700", "K803309", "K963578", "K960449", "K883468", "K881328", "K861359", "K760677", "K875057", "K001492", "K123217", "K920020", "K043074", "K760612", "K790691", "K870380", "K790300", "K821090", "K142288", "K921930", "K160092", "K000645", "K131819", "K093869", "K832014", "K915760", "K802113", "K111159", "K101016", "K052303", "K924544", "K800593", "K112135", "K081473", "K152427", "K972310", "K904606", "K955416", "K920364", "K173226", "K133985", "K941811", "K831429", "K862748", 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