Baxter Healthcare Corporation: Medical Device Recall in 2024 - (Recall #: Z-0325-2025)

Hillrom Welch Allyn XScribe Cardiac Stress Testing System; Programmable Diagnostic Computer

Class II

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.

Software Versions: Software Version V6.0.0 V6.3.2, Release Date 02-Jul-2015 Units: 1) UDI/DI 00732094259032, Serial Numbers: 115340269178, 117060553883, 117060553884, 117060553885, 119230003169; 2) UDI/DI 00732094259070, Serial Numbers: 117130559202, 117130559203, 117130559204; 3) UDI/DI 00732094259100, Serial Numbers: 116270497046, 117190567440; 4) UDI/DI 00732094259148, Serial Numbers: 117350583961, 119060000843, 122090000529; 5) UDI/DI 00732094259179, Serial Numbers: 116240458434, 116500543985, 120480000930; 6) UDI/DI 00732094259230, Serial Numbers: 118160628177; 7) UDI/DI 00732094259261, Serial Numbers: 117470596306; 8) UDI/DI 00732094259285, Serial Numbers: 118100618358, 116110348774, 116490541753, 117430591185, 117510601740; 9) UDI/DI 00732094259292, Serial Numbers: 116460537153, 118490000226; 10) 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; 11) UDI/DI 00732094259315, Serial Numbers: 117130559201; 12) UDI/DI 00732094259322, Serial Numbers: 117350583998, 117500601523; 13) UDI/DI 00732094259346, Serial Numbers: 116110347146, 116110347144; 14) UDI/DI 00732094259445, Serial Numbers: 116430533831, 116430533832; 15) 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; 16) 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; 17) UDI/DI 00732094259612, Serial Numbers: 116120365528; 18) 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; 19) UDI/DI 00732094259681, Serial Numbers: 118520000552, 118520000554, 119470001920, 121060000078, 121370000332, 122100000410, 122130000800, 122220000669, 122220000670; 20) UDI/DI 00732094259735, Serial Numbers: 118180635067, 118180635066, 118180635065; 21) UDI/DI 00732094259766, Serial Numbers: 118190636601, 118190636602, 118190636603, 118190636604, 118190636605, 118480000844, 118480000845; 22) UDI/DI 00732094259810, Serial Numbers: 118180635071, 118180635070, 118180635069, 118180635068, 119090000517, 119090000518, 122440001777, 124100001981, 124100001982; 23) UDI/DI 00732094259889, Serial Numbers: 117390588078; 24) UDI/DI 00732094259919, Serial Numbers: 116460538218, 116460538215, 116460538216, 116460538217; 25) UDI/DI 00732094259971, Serial Numbers: 118130624172, 118130624171, 118130624170, 118130624169; 26) UDI/DI 00732094260120, Serial Numbers: 116500544084, 119250000576, 120180001429; 27) UDI/DI 00732094260137, Serial Numbers: 117380586599, 117380586600; 28) UDI/DI 00732094260151, Serial Numbers: 117160563860, 117160563861, 117160563861; 29) UDI/DI 00732094260199, Serial Numbers: 117510602780, 117510602781; 30) 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; 31) 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; 32) UDI/DI 00732094260304, Serial Numbers: 117140562699, 117140562700; 33) UDI/DI 00732094260342, Serial Numbers: 116510545162; 34) 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; 35) UDI/DI 00732094260434, Serial Numbers: 118300000860, 118460001730, 118460001732, 118480000841, 119130000112, 119130000113, 119130000114, 119200001280, 119200001614, 119380001489, 121150000434, 121150000435, 121360000218, 121450000733, 121520000986, 121520000987, 121520000988, 121520000989, 119380001489; 36) 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; 37) UDI/DI 00732094260533, Serial Numbers: 117390588115, 117390588116, 117390588117, 117390588118, 111130075526; 38) 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; 39) UDI/DI 00732094260601, Serial Numbers: 113480185300; 40) 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; 41) UDI/DI 00732094260731, Serial Numbers: 116120368670; 42) UDI/DI 00732094260816, Serial Numbers: 113240166924, 117080554664, 117080554665, 117220571840, 118280000973, 118480000833; 43) UDI/DI 00732094260847, Serial Numbers: 117520603150; 44) UDI/DI 00732094260885, Serial Numbers: 116340523128, 116350524044. 117370586263; 45) UDI/DI 00732094260892, Serial Numbers: 117380586444; 46) UDI/DI 00732094260960, Serial Numbers: 117470596307, 118050609226; 47) UDI/DI 00732094260991, Serial Numbers: 116500543942, 116500543943, 116500543944, 116500543945, 116500543946; 48) UDI/DI 00732094261004, Serial Numbers: 116390529064; 49) UDI/DI 00732094261028, Serial Numbers: 116460538216, 116460538217, 116110348790, 116070311448, 117370586263, 116070311445, 116070311446, 116070311447, 119380001488; 50) 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; 51) UDI/DI 00732094261196, Serial Numbers: 118270000496, 118270000497, 118270000498, 118310000442, 118310000443, 118310000444, 118310000445, 118310000446, 118310000447, 118460002316; 52) UDI/DI 00732094294255, Serial Numbers: 118280001663, 118280001664, 118450000678, 118450000679, 118280001663; 53) UDI/DI 00732094294538, Serial Numbers: 120140002538, 120140002539, 120320001826, 120320001827, 121060001018, 122220000671; 54) UDI/DI 00732094294545, Serial Numbers: 122170001364; 55) UDI/DI 00732094295429, Serial Numbers: 118360000421, 118370002214; 56) UDI/DI 00732094296303, Serial Numbers: 119420001730, 119420001731, 119420001732, 119420001733, 119420001734, 119420001735, 119420001736, 121510000646, 121510000647, 121500000303, 123180000483, 123180000484; 57) UDI/DI 00732094299908, Serial Numbers: 11810623357; 58) UDI/DI 00732094299915, Serial Numbers: 118120623355, 118120623356, 118120623365, 118120623359, 118120623363; 59) UDI/DI 00732094301472, Serial Numbers: 117500600621, 120440000589, 120440000590, 120440000591, 120440000592, 120440000593, 122440001762, 21120440000592, 12244001762, 122470000639; 60) UDI/DI 00732094302974, Serial Numbers: 119020000643, 121320001539, 121320001540, 121320001541, 12341, 12342, 12343, 121420001245, 121420001246, 121420001247, 121420001248; 61) UDI/DI 00732094316926, Serial Numbers: 119140001089, 119460000150, 119460000151; 62) UDI/DI 00732094320176, Serial Numbers: 122360001053, ....; 63) UDI/DI 00732094320183, Serial Numbers: 120110001003, 121050001860; 64) 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; 65) UDI/DI 00732094337518, Serial Numbers: 115350269606, 120270000572, 121470000326; 66) UDI/DI 00732094338805, Serial Numbers: 114340225721; 67) UDI/DI 00732094339444, Serial Numbers: 120400001336; 68) 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; 69) UDI/DI 00817655021997, Serial Numbers: 117370585639

Worldwide distribution.

Voluntary: Firm initiated