Z-0320-2025Class II

Hillrom Welch Allyn HScribe Holter System; ambulatory monitoring

Name: Z-0320-2025 Hillrom Welch Allyn HScribe Holter System; ambulatory monitoring
Creator: Baxter Healthcare Corporation
Published: 2024-10-11
License: https://open.fda.gov/license/

Baxter Healthcare Corporation / initiated 2024-10-11 / Open, Classified / root cause: software

FDA source

Baxter Healthcare Corporation began a recall of Hillrom Welch Allyn HScribe Holter System; ambulatory monitoring on 2024-10-11. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as software.

Recall record

Recall number: Z-0320-2025
Classification: Class II
Status: Open, Classified
Initiated: 2024-10-11
Posted: 2024-11-07
Recalling firm: Baxter Healthcare Corporation
Product: Hillrom Welch Allyn HScribe Holter System; ambulatory monitoring
Product code: MLO Electrocardiograph, Ambulatory, With Analysis Algorithm
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.
Root cause tag: software
FDA root cause: Software design
Action: 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.
Quantity in commerce: 599 units
Distribution: Worldwide distribution.
Product codes and lots: 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;

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0320-2025
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0320-2025	Class II	Ongoing	Voluntary: Firm initiated	2024-11-13	2024-11-07
Z-0321-2025	Class II	Ongoing	Voluntary: Firm initiated	2024-11-13	2024-11-07
Z-0322-2025	Class II	Ongoing	Voluntary: Firm initiated	2024-11-13	2024-11-07
Z-0323-2025	Class II	Ongoing	Voluntary: Firm initiated	2024-11-13	2024-11-07
Z-0324-2025	Class II	Ongoing	Voluntary: Firm initiated	2024-11-13	2024-11-07
Z-0325-2025	Class II	Ongoing	Voluntary: Firm initiated	2024-11-13	2024-11-07

Product code MLO

K004017Class IIH-ScribeMortara Instrument, Inc. / cleared 2001-06-11

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)