Hillrom Welch Allyn RScribe 12-Lead Electrocardiograph System; Electrocardiograph
This recall is currently active, issued November 7, 2024. It was issued by Baxter Healthcare Corporation.
- Company
- Baxter Healthcare Corporation
- Recall Initiated
- October 11, 2024
- Posted
- November 7, 2024
- Recall Number
- Z-0322-2025
- Quantity
- 399 units
- Firm Location
- Deerfield, IL
- Official Source
- View on FDA website ↗
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.
Distribution
Worldwide distribution.
Lot / Code Info
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
Root Cause
Software design
Action Taken
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.