Welch Allyn HScribe Holter System (Baxter) – File ID Duplication (2024)
Hazard assessment based on recall description.
This AI-generated summary is provided for general informational purposes only and is derived from publicly available recall notices. It supplements but does not replace official agency classifications or safety instructions.
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According to the U.S. Food and Drug Administration (FDA)
Product
Hillrom Welch Allyn HScribe Holter System; ambulatory monitoring
Brand
Baxter Healthcare Corporation
Lot Codes / Batch Numbers
Software Versions: Software Version V4.0.0 V4.34, release date 26-Oct-2005, Software Version V6.1.0 V6.4.1, release date 02-Aug-2016 Units: 1) UDI/DI 00732094263992, Serial Numbers: 119470002280, 2) UDI/DI 00732094264043, Serial Numbers: 112320127784, 113500186660, 114300222272, 115350270164, 116490541266, 117360584925, 117440592623, 117440592624, 117440592625, 117510602023, 118330000138, 118180634304, 118480000469, 3) UDI/DI 00732094264074, Serial Numbers: 113240166856, 114070193758, 118060610823, 118130624139, 118130624138, 118110619525, 118110619527, 118110619528, 118110619526, 118200638074, 120070000189, 120070000190, 120070000191, 120070000192, 120070000193, 21120070000193, 120420002116, 120420002117, 120420002118, 120420002119, 120420002120, 120460000676, 120460000677, 120460000678, 120460000679, 120460000680, 122090001190, 122200001820, 4) UDI/DI 00732094264111, Serial Numbers: 117490600194, 5) UDI/DI 00732094296297, Serial Numbers: 118390000385, UNKNOWN1, 118390000386, 119420001709, 119420001710, 119420001711, 119420001712, 119420001713, 119420001714, 119420001715, 6) UDI/DI 00817655020112, Serial Numbers: 115500283784, 116400529497, 116400530902, 116510545319, 117060553932, 117210570072, 117240573532, 117280578279, 117300580470, 117320582614, 118070612285, 118110619348, 118080615002, 115500284289, 116480540153, 118220000011, 118200637011, 119050000162, 119170000577, 119210001714, 119400001607, 119470000313, 120090000835, 121050000782, 121060000719, 121400000314, 7) UDI/DI 00817655020129, Serial Numbers: 116400529498, 116400529499, 116400529500, 116400529501, 116400529502, 116400529503, 116520545635, 117020550528, 117120556670, 117190568282, 117210570495, 117370585793, 117370585791, 117370585792, 117390588072, 117510602159, 118270000671, 118340000888, 118370001918, IBE-6AA-AXXXB, 119200001821, 119240000737, 119280000998, 119340002048, 119390001266, 119490001403, 119500000900, 120310001386, 122250000669, 8) UDI/DI 00817655020228, Serial Numbers: 117310581681, 118090617165, 118110621029, 118130624382, 118150627491, 118160630556, 116400530264, 117180566574, 117270577494, 117270577495, 117250575587, 117370586257, 117400588935, 117460595447, 117480597608, 118090617166, 118100617899, 118180634180, 118240001064, 118270000349, 118280001255, 118280001256, 118290000866, 118310001198, 118350001195, 118370000769, 118370000770, 119080001404, 119130001332, 119170000628, 119180001032, 119210001726, 119240001008, 119240001199, 119270000103, 119270000546, 119450000814, 119470000539, 119470000540, 119510001672, 119510001673, 120020001043, 120080000595, 120090000596, 120090000597, 120110000549, 120140001040, 120200000126, 120310001427, 120320000692, 120330000289, 120130000377, 120500000717, 120520000195, 120520000196, 121010000369, 121010000370, 121030001105, 21121010000369, 121070000806, 121070000807, 121070000808, 121100000588, 121100000589, 121100000590, 121100000591, 121180000597, 121270000245, 121270000246, 121270000247, 121300000833, 121380000280, 121380000281, 121380000282, 121480000742, 121480000743, 121480000744, 121480000745, 122120000261, 122120000262, 122120000263, 122120000264, 122210000694, 122210000695, 122240000750, 122240000751, 122240000752, 122240000753, 122260000197, 122260000198, 122360000824, 122440000305, 122440000306, 122440000307, 122440000308, 123030001934, 123030001935, 123030001936, 123030001937, 123080000553, 123080000554, 123080000555, 123080000556, 123130001599, 123130001600, 123130001601, 123130001602, 123200001547, 123240002272, 123240002273, 123240002274, 123240002275, 123150000775, 123440000181, 122310000455, 123520001474, 124050000692, 123520001479, 124090001301, 112340129777, 117250575587, 118110621029, 121380000282, 123240002275, 123440000158, 124050000692, 124090001301, 124190001471, 124220000331, 124250001191, 124290002060, 124310000453, 9) UDI/DI 00817655020365, Serial Numbers: 118120622023, 118120622022, 110490066007, 114400231139, 114460236305, 115050243715, 116430534192, 116430534193, 117400588939, 117460595452, 118180634590, 118250002188, 118280001249, 118290000002, 118290000003, 118310000690, 118310000691, 118310000692, 118310000693, 118310000694, 118310000695, 118310000696, 118340000899, 118520000583, 119060001356, 119090000896, 119150000330, 119180001176, 119270000092, 119450001895, 119450001896, 120120000571, 120190000066, 120190000067, 120190000068, 120190000069, 120190000070, 120190000071, 120190000072, 120260001471, 120410000422, 121050000796, 121060001456, 121060001457, 121080001844, 121080001845, 121080001846, HSCRIBE-RECOVERY-5, HSCRIBE-RECOVERY-6, 121220000167, 121220000168, 121230000652, 121280000779, 121280000780, 121310001053, 121310001054, 121330000559, 121330000560, 121400000319, 121430000526, 121440000121, 121440000122, 121440000123, 121440000124, 121440000125, 122020000505, 122020000506, 122020000507, 122020001888, 122020001889, 122020001890, 122080000268, 122080000269, 122080000270, 122080000747, 122080000748, 817655022277, 122130000796, 122150001151, 122150001152, 122150001614, 122210000110, 122240000748, 122240000749, 122240001641, 122240001642, 121480000560, 122260000180, 122320000168, 122320000169, 122320000170, 122320000171, 122320000172, 122320000173, 122320000174, 122320000175, 122320000176, 122320000177, 122320000178, 122340000211, 122350000042, 122350000043, 122350000044 122380002037, ., .., 122410000843, 122430000407, 122430000408, 122430000409, 122430000410, 123070001753, 123070001754, 123090001093, 123090001094, 123090001095, 123090001096, 123090001097, 123090001098, 123090001099, 123090001100, 123090001101, 123090001102, 123090001103, 123090001104, 123090001105, 123090001106, 123090001107, 123100001952, 123150001474, 123150001475, 123200001033, 123200001034, 123200001035, 123200001036, 122500002290, 123280000131, 123310001086, 123310001087, 123320000985, 123460001090, 124040001764, 124040001765, 124050001622, 115170254646, 122080000748, 122350000043, 122380002037, 122410000843, 122430000408, 123280000131, 123460001090, 124090000926, 124090000927, 124100002180, 124100002181, 124100002182, 124100002183, 124100002184, 124100002185, 124100002186, 124100002187, 124100002188, 124100002189, 124100002190, 124100002191, 124100002192, 124100002193, 124100002194, 124100002195, 124100002196, 124100002197, 124100002198, 124100002199, 124130001123, 124130001124, 124130001125, 124130001126, 124130001127, 124130001128, 124130001129, 124130001130, 124130001131, 124130001132, 124170000844, 124170000845, 124170000846, 124170000847, 124170001423, 10) UDI/DI 00817655020426, Serial Numbers: 116440535695, 11) UDI/DI 00817655021744, Serial Numbers: 112380133932, 116420532941, 116420532942, 117080554674, 117170565221, 117170565222, 117170565223, 117170565224, 117170565225, 117170565226, 117170565227, 117170565228, 117380586935, 117460594758, 117460594759, 117460595838, 117490599035, 117490599036, 117490599037, 117490599038, 117490599039, 117490599040, 117490599041, 118050610027, 118100617236, 118450001277, 118450001278, 118450001279, 118450001280, 118450001281, 118450001282, 118450001283, 118450001284, 118450001285, 118450001286, 119300001269, 119300001270, 119300001271, 119300001272, 119300001273, 119300001274, 119300001275, 119300001276, 119300001277, 119300001278, 119320000898, 120100002186, 120100002187, 120100002188, 120100002189, 120100002190, 121200000828, 121200000829, 121200000830, 121200000831, 121200000832, 121410001289, 121410001290, 121410001291, 121410001292, 121410001293, 121410001294, 121410001295, 121410001296, 121410001297, 121410001298, 123030001372, 123030001373, 123030001374, 123030001375, 123030001376, 123030001377, 123180000490, 123180000491, 123180000492, 123180000493, 123180000494, 12l) UDI/DI 00817655022161, Serial Numbers: 112380133418, 113270169359, 114100196535, 114210213291, 114330225015, 114480237574, 115210256907, 115310266462, 116130382982, 117460594752, 117460594753, 117460594754, 117460594755, 117460594756, 117460594757, 118160629854, 119160000035, 119170000424, 119390001279, 119470001902, 120020000549, 120040000379, 120040001033, 120090000594, 120350000339, 121090000169, 121100000481, 121220000166, 121270000241, 121370000462, 121470000316, 122150001153, 122220000611, 122250000668, 122380002036, 122410000838, 122480002081, 123010001110, 123010001111, 10081765502216100, m) None, Serial Numbers: 110460064411, 111420097209, 111490102308, 110110037447, 110110037902, 110130040679, 110130040386, 110260052782, 110300055017, 110460064409, 110490065972, 110490065973, 110480065644, 110510067535, 111030070004, 111080072938, 111130075520, 111130075528, 111160078026, 111170078940, 111160078346, 111180079818, 111190080488, 111190080489, 111240084631, 111270086586, 111280086683, 111320089454, 111330090406, 111400095714, 111400096095, 111410096343, 111410096868, 111420097208, 111480101785, 111490102298, 111500103121, 112020106107, 112010105069, 112100110612, 112120111947, 112370132376, 112480143987, 112200117405, 110160042488, 110160042628, 110440063372, 110490065751, 110500066872, 111280086684, 117330583137
Products Sold
Software Versions: Software Version V4.0.0 V4.34, release date 26-Oct-2005; Software Version V6.1.0 V6.4.1, release date 02-Aug-2016 Units: 1) UDI/DI 00732094263992, Serial Numbers: 119470002280; 2) UDI/DI 00732094264043, Serial Numbers: 112320127784, 113500186660, 114300222272, 115350270164, 116490541266, 117360584925, 117440592623, 117440592624, 117440592625, 117510602023, 118330000138, 118180634304, 118480000469; 3) UDI/DI 00732094264074, Serial Numbers: 113240166856, 114070193758, 118060610823, 118130624139, 118130624138, 118110619525, 118110619527, 118110619528, 118110619526, 118200638074, 120070000189, 120070000190, 120070000191, 120070000192, 120070000193, 21120070000193, 120420002116, 120420002117, 120420002118, 120420002119, 120420002120, 120460000676, 120460000677, 120460000678, 120460000679, 120460000680, 122090001190, 122200001820; 4) UDI/DI 00732094264111, Serial Numbers: 117490600194; 5) UDI/DI 00732094296297, Serial Numbers: 118390000385, UNKNOWN1, 118390000386, 119420001709, 119420001710, 119420001711, 119420001712, 119420001713, 119420001714, 119420001715; 6) UDI/DI 00817655020112, Serial Numbers: 115500283784, 116400529497, 116400530902, 116510545319, 117060553932, 117210570072, 117240573532, 117280578279, 117300580470, 117320582614, 118070612285, 118110619348, 118080615002, 115500284289, 116480540153, 118220000011, 118200637011, 119050000162, 119170000577, 119210001714, 119400001607, 119470000313, 120090000835, 121050000782, 121060000719, 121400000314; 7) UDI/DI 00817655020129, Serial Numbers: 116400529498, 116400529499, 116400529500, 116400529501, 116400529502, 116400529503, 116520545635, 117020550528, 117120556670, 117190568282, 117210570495, 117370585793, 117370585791, 117370585792, 117390588072, 117510602159, 118270000671, 118340000888, 118370001918, IBE-6AA-AXXXB, 119200001821, 119240000737, 119280000998, 119340002048, 119390001266, 119490001403, 119500000900, 120310001386, 122250000669; 8) UDI/DI 00817655020228, Serial Numbers: 117310581681, 118090617165, 118110621029, 118130624382, 118150627491, 118160630556, 116400530264, 117180566574, 117270577494, 117270577495, 117250575587, 117370586257, 117400588935, 117460595447, 117480597608, 118090617166, 118100617899, 118180634180, 118240001064, 118270000349, 118280001255, 118280001256, 118290000866, 118310001198, 118350001195, 118370000769, 118370000770, 119080001404, 119130001332, 119170000628, 119180001032, 119210001726, 119240001008, 119240001199, 119270000103, 119270000546, 119450000814, 119470000539, 119470000540, 119510001672, 119510001673, 120020001043, 120080000595, 120090000596, 120090000597, 120110000549, 120140001040, 120200000126, 120310001427, 120320000692, 120330000289, 120130000377, 120500000717, 120520000195, 120520000196, 121010000369, 121010000370, 121030001105, 21121010000369, 121070000806, 121070000807, 121070000808, 121100000588, 121100000589, 121100000590, 121100000591, 121180000597, 121270000245, 121270000246, 121270000247, 121300000833, 121380000280, 121380000281, 121380000282, 121480000742, 121480000743, 121480000744, 121480000745, 122120000261, 122120000262, 122120000263, 122120000264, 122210000694, 122210000695, 122240000750, 122240000751, 122240000752, 122240000753, 122260000197, 122260000198, 122360000824, 122440000305, 122440000306, 122440000307, 122440000308, 123030001934, 123030001935, 123030001936, 123030001937, 123080000553, 123080000554, 123080000555, 123080000556, 123130001599, 123130001600, 123130001601, 123130001602, 123200001547, 123240002272, 123240002273, 123240002274, 123240002275, 123150000775, 123440000181, 122310000455, 123520001474, 124050000692, 123520001479, 124090001301, 112340129777, 117250575587, 118110621029, 121380000282, 123240002275, 123440000158, 124050000692, 124090001301, 124190001471, 124220000331, 124250001191, 124290002060, 124310000453; 9) UDI/DI 00817655020365, Serial Numbers: 118120622023, 118120622022, 110490066007, 114400231139, 114460236305, 115050243715, 116430534192, 116430534193, 117400588939, 117460595452, 118180634590, 118250002188, 118280001249, 118290000002, 118290000003, 118310000690, 118310000691, 118310000692, 118310000693, 118310000694, 118310000695, 118310000696, 118340000899, 118520000583, 119060001356, 119090000896, 119150000330, 119180001176, 119270000092, 119450001895, 119450001896, 120120000571, 120190000066, 120190000067, 120190000068, 120190000069, 120190000070, 120190000071, 120190000072, 120260001471, 120410000422, 121050000796, 121060001456, 121060001457, 121080001844, 121080001845, 121080001846, HSCRIBE-RECOVERY-5, HSCRIBE-RECOVERY-6, 121220000167, 121220000168, 121230000652, 121280000779, 121280000780, 121310001053, 121310001054, 121330000559, 121330000560, 121400000319, 121430000526, 121440000121, 121440000122, 121440000123, 121440000124, 121440000125, 122020000505, 122020000506, 122020000507, 122020001888, 122020001889, 122020001890, 122080000268, 122080000269, 122080000270, 122080000747, 122080000748, 817655022277, 122130000796, 122150001151, 122150001152, 122150001614, 122210000110, 122240000748, 122240000749, 122240001641, 122240001642, 121480000560, 122260000180, 122320000168, 122320000169, 122320000170, 122320000171, 122320000172, 122320000173, 122320000174, 122320000175, 122320000176, 122320000177, 122320000178, 122340000211, 122350000042, 122350000043, 122350000044 122380002037, ., .., 122410000843, 122430000407, 122430000408, 122430000409, 122430000410, 123070001753, 123070001754, 123090001093, 123090001094, 123090001095, 123090001096, 123090001097, 123090001098, 123090001099, 123090001100, 123090001101, 123090001102, 123090001103, 123090001104, 123090001105, 123090001106, 123090001107, 123100001952, 123150001474, 123150001475, 123200001033, 123200001034, 123200001035, 123200001036, 122500002290, 123280000131, 123310001086, 123310001087, 123320000985, 123460001090, 124040001764, 124040001765, 124050001622, 115170254646, 122080000748, 122350000043, 122380002037, 122410000843, 122430000408, 123280000131, 123460001090, 124090000926, 124090000927, 124100002180, 124100002181, 124100002182, 124100002183, 124100002184, 124100002185, 124100002186, 124100002187, 124100002188, 124100002189, 124100002190, 124100002191, 124100002192, 124100002193, 124100002194, 124100002195, 124100002196, 124100002197, 124100002198, 124100002199, 124130001123, 124130001124, 124130001125, 124130001126, 124130001127, 124130001128, 124130001129, 124130001130, 124130001131, 124130001132, 124170000844, 124170000845, 124170000846, 124170000847, 124170001423; 10) UDI/DI 00817655020426, Serial Numbers: 116440535695; 11) UDI/DI 00817655021744, Serial Numbers: 112380133932, 116420532941, 116420532942, 117080554674, 117170565221, 117170565222, 117170565223, 117170565224, 117170565225, 117170565226, 117170565227, 117170565228, 117380586935, 117460594758, 117460594759, 117460595838, 117490599035, 117490599036, 117490599037, 117490599038, 117490599039, 117490599040, 117490599041, 118050610027, 118100617236, 118450001277, 118450001278, 118450001279, 118450001280, 118450001281, 118450001282, 118450001283, 118450001284, 118450001285, 118450001286, 119300001269, 119300001270, 119300001271, 119300001272, 119300001273, 119300001274, 119300001275, 119300001276, 119300001277, 119300001278, 119320000898, 120100002186, 120100002187, 120100002188, 120100002189, 120100002190, 121200000828, 121200000829, 121200000830, 121200000831, 121200000832, 121410001289, 121410001290, 121410001291, 121410001292, 121410001293, 121410001294, 121410001295, 121410001296, 121410001297, 121410001298, 123030001372, 123030001373, 123030001374, 123030001375, 123030001376, 123030001377, 123180000490, 123180000491, 123180000492, 123180000493, 123180000494; 12l) UDI/DI 00817655022161, Serial Numbers: 112380133418, 113270169359, 114100196535, 114210213291, 114330225015, 114480237574, 115210256907, 115310266462, 116130382982, 117460594752, 117460594753, 117460594754, 117460594755, 117460594756, 117460594757, 118160629854, 119160000035, 119170000424, 119390001279, 119470001902, 120020000549, 120040000379, 120040001033, 120090000594, 120350000339, 121090000169, 121100000481, 121220000166, 121270000241, 121370000462, 121470000316, 122150001153, 122220000611, 122250000668, 122380002036, 122410000838, 122480002081, 123010001110, 123010001111, 10081765502216100; m) None, Serial Numbers: 110460064411, 111420097209, 111490102308, 110110037447, 110110037902, 110130040679, 110130040386, 110260052782, 110300055017, 110460064409, 110490065972, 110490065973, 110480065644, 110510067535, 111030070004, 111080072938, 111130075520, 111130075528, 111160078026, 111170078940, 111160078346, 111180079818, 111190080488, 111190080489, 111240084631, 111270086586, 111280086683, 111320089454, 111330090406, 111400095714, 111400096095, 111410096343, 111410096868, 111420097208, 111480101785, 111490102298, 111500103121, 112020106107, 112010105069, 112100110612, 112120111947, 112370132376, 112480143987, 112200117405, 110160042488, 110160042628, 110440063372, 110490065751, 110500066872, 111280086684, 117330583137;
Baxter Healthcare Corporation is recalling Hillrom Welch Allyn HScribe Holter System; ambulatory monitoring due to There is the potential for exam files being assigned duplicate Unique Identifiers (UIDs),. If the system receiving the DICOM file (e.g., Picture Arch. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
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.
Recommended Action
Per FDA guidance
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.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026