—#210585

Product

Hillrom Welch Allyn HScribe Holter System; ambulatory monitoring

FDA product code: MLO — Electrocardiograph, Ambulatory, With Analysis Algorithm
Device class: Class 2
Medical specialty: Cardiovascular
510(k) numbers: K004017
Affected lot / code info: 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;

Why it was recalled

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 (FDA determination)

Software design

Action the firm took

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.

Recalling firm

Firm: Baxter Healthcare Corporation
Address: 1 Baxter Pkwy, Deerfield, Illinois 60015-4625

Distribution

Distribution pattern: Worldwide distribution.

Timeline

Recall initiated: 2024-10-11
Posted by FDA: 2024-11-07
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #210585. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.