Baxter Healthcare Corporation: Medical Device Recall in 2024 - (Recall #: Z-0322-2025)

Hillrom Welch Allyn RScribe 12-Lead Electrocardiograph System; Electrocardiograph

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 V6.2.3, Release Date 02-Jul-2015; Software Version V7.0.0, Release Date 02-Oct-2017 Units: 1) UDI/DI 00732094262957, Serial Numbers: 118100617841, 118250001722, 118480000511, 119140000676, 119150000331, 119180000544, 119180000545, 119180000546, 119180000547, 119180000548, 119180000549, 119180000550, 119180000551, 119340002011, 119340002012, 119460000996, 119470001912, 120110000469, 120130001657, 120160001284, 120420002132, 120420002133, 120420002134, 120420002135, 120420002136, 121330000576, 121330000577, 121330000578, 121330000579, 121330000580, 121330000581, 121330000582, 121390000797; 2) UDI/DI 00732094263046, Serial Numbers: 118460001965, 119150000243, 119390000178, 119390000179, 119500000539, 120480001168, 9069365, 121030000268, 121130001324, 121270000249, 121380000289, 121480000761, 121480000762, 121480000763, 121480000764, 121480000765, 121480000766, 121480000767, 121480000768, 121480000769, 121480000770, 121480000771, 121490000809, 121490000810, 121490000811, 121370002215, 122020001003, 122020001004, 122020001005, 122020001006, 122020001007, 122020001008, 122020001009, 122020001010, 122020001011, 122020001012, 122020001013, 122050001754, 122050001755, 122050001756, 122050001757, 122050001758, 122050001759, 122040000338, 122040000339, 122040000341, 122050000662, 122050000667, 122120002583, 122120002584, 122120002585, 122120002586, 122120002587, 122120002588, 122120002589, 122120002590, 122120002591, 122120002592, 122120002593, 122120002594, 122160000170, 122160000171, 122160000172, 122200000716, 122200000717, 122200000718, 122200000719, 123060000574, 123060000575, 123060000576, 123060000577, 123060000578, 123060000579, 123060000580, 123060000581, 123060000582, 123100001462, 123100001463, 122450001687, 122450001690, 122450001691, 122450001693, 122120002594, 122200000716, 123060000576, 123060000578, 123060000581, 123060000582, 123320000688, 123320000689; 3) UDI/DI 00732094263107, Serial Numbers: 116440534586, 116440534587, 116440534588, 116440534589, 116440534590, 116440534591, 116440534592, 116440534593, 116440534594, 116440534595, 116440534596, 116440534597, 116440534598, 116440534599, 116440534600, 117010549214, 117010549215, 117010549216, 117010549217, 117010549218, 117010549219, 117010549220, 117010549221, 117010549222, 117010549223, 117130559079, 117130559080, 117130559081, 117130559082, 117130559083, 117130559084, 117130559085, 117130559086, 117130559087, 117130559088, 117130559089, 117130559090, 117130559091, 117130559092, 117130559093, 117270577247, 117270577248, 117270577249, 117270577250, 117270577251, 117270577252, 117270577253, 117270577254, 117270577255, 117270577256, 117360584807, 117360584808, 117360584809, 117360584810, 117360584811, 117360584812, 117360584813, 117360584814, 117360584815, 117360584816, 118110619366, 118110619367, 118110619368, 118110619369, 118110619370, 118110619371, 118110619372, 118110619373, 118110619374, 118110619375, 118450001287, 118450001288, 118450001289, 118450001290, 118450001291, 118450001292, 118450001293, 118450001294, 118450001295, 118450001296, 119240000205, 119240000206, 119240000207, 119240000208, 119240000209, 119240000210, 119240000211, 119240000212, 119240000213, 119240000214, 119240000216, 119240000217, 119240000218, 119240000219, 119240000220, 119240000221, 119240000222, 119240000223, 119240000224, 119240000225, 119300001280, 119300001281, 119300001282, 119300001283, 119300001284, 119300001285, 119300001286, 119300001287, 119300001288, 119300001289, 121030000675, 121030000676, 121030000677, 121030000678, 121030000679, 121030000680, 121030000681, 121030000682, 121030000683, 121030000684, 121040000881, 121040000882, 121040000883, 121040000884, 121040000885, 121040000886, 121040000887, 121040000888, 121040000889, 121040000890, 121060000036, 121060000037, 121060000038, 121060000039, 121060000040, 121060000041, 121060000042, 121060000043, 121060000044, 121060000045, 121410001269, 121410001270, 121410001271, 121410001272, 121410001273, 121410001274, 121410001275, 121410001276, 121410001277, 121410001278, 121410001279, 121410001280, 121410001281, 121410001282, 121410001283, 121410001284, 121410001285, 121410001286, 121410001287, 121410001288, 122280000939, 122280000940, 122280000941, 122280000942, 122280000943, 122280000944, 122280000945, 122280000946, 122280000947, 122280000948, 122280000949, 122280000950, 122280000951, 122280000952, 122280000953, 122280000954, 122280000955, 122280000956, 122280000957, 122280000958, 122280000959, 122280000960, 122280000961, 122280000962, 122280000963, 122280000964, 122280000965, 122280000966, 122280000967, 122280000968, 122520001054, 122520001055, 122520001056, 122520001057, 122520001058, 122520001059, 122520001060, 122520001061, 122520001062, 122520001063, 123010000269, 123010000270, 123010000271, 123010000272, 123010000273, 123010000274, 123010000275, 123010000276, 123010000277, 123010000278, 122520001054; 4) UDI/DI 00732094263138, Serial Numbers: 1, 2; 5) UDI/DI 00732094263152, Serial Numbers: 117500601521; 6) UDI/DI 00732094263169, Serial Numbers: 118120622041, 118120622040, 118120622039, 118120622038, 118120622037, 118120622036, 118120622035, 118120622034, 118120622033, 118120622032; 7) UDI/DI 00812345027822, Serial Numbers: 116270501517, 117270576947; 8) UDI/DI 00812345027839, Serial Numbers: 116270499720, 116290516803, 116480540314, 117050553486, 117050553487, 117110556359, 117170566163, 117170566164, 117170566165, 117170566166, 117170566167, 117170566168, 117170566169, 117170566171, 117170566172, 117170566170, 117340583183, 117340583184, 117340583185, 117340583186, 117340583187, 117340583188, 117340583189, 117340583190, 117340583191, 117340583192, 117350584681, 116270499720; 9) UDI/DI 00817655020280, Serial Numbers: 116420532965, 116450536831, 116460538001, 117010549242, 117260576252, 117260576918, 117430592085, 117430592086, 117430592087, 117430592088, 117430592083; 10) UDI/DI 00817655021362, Serial Numbers: 117130560315, 117130560316, 117130560317; 11) UDI/DI 00817655022246, Serial Numbers: 118390000403; 12) UDI/DI none, Serial Numbers: 117220571712, 117290578777, 117290578778, 117290578779, 117290578780, 117290578781, 117290578782

Worldwide distribution.

Voluntary: Firm initiated