FDA Enforcement Class II Ongoing

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

Recall: Z-0325-2025 · Reported November 13, 2024

Enforcement

Recall Number: Z-0325-2025
Event ID: 95559
Classification: Class II
Status: Ongoing
Product Type: Devices
Firm: Baxter Healthcare Corporation
Voluntary / Mandated: Voluntary: Firm initiated
Initial Notification: Letter
Report Date: November 13, 2024
Initiation Date: October 11, 2024
Classification Date: November 7, 2024
Address: 1 Baxter Pkwy, N/A, Deerfield, IL, 60015-4625, United States

Description

Reason

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.

Code Info

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

Distribution

Worldwide distribution.

Quantity

766 units