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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 95559

6 recalled-product records grouped only because every row carries this exact official event ID.

Open FDA event record

Event summary

Timeline bucket
October 11, 2024
Product types
Device
Classifications
Class II
Statuses
Ongoing
Recalling firm wording
Baxter Healthcare Corporation

Dossier provenance

Source snapshots represented here

  • openFDA Device Enforcement Report-date coverage June 20, 2012–July 08, 2026 Known gap: openFDA describes 2004-present coverage, but the current export has no report-date records in this interval.
  • openFDA Device Recall event_date_initiated coverage June 01, 1997–June 30, 2026

Enforcement coverage uses report dates; product initiation dates can precede those bounds. Device-enrichment coverage uses FDA event_date_initiated.

How coverage and grouping work

Complete imported group

Every recalled product in this event

6 official enforcement rows

Product dates, classifications, firms, and source wording remain attached to their individual rows. Opening this dossier never hides products that did not match a prior timeline filter.

device · product 1 of 6

Hillrom Welch Allyn HScribe Holter System; ambulatory monitoring

Z-0320-2025
Recall number
Z-0320-2025
Initiated
October 11, 2024
Classification
Class II
Status
Ongoing
Quantity
599 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
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.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Software design

Compare all device evidence states

Inspect official wording and provenance

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.

Code information

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;

Distribution pattern

Worldwide distribution.

device · product 2 of 6

Hillrom Welch Allyn Q-Stress Cardiac Stress Testing System; cardiac stress test

Z-0321-2025
Recall number
Z-0321-2025
Initiated
October 11, 2024
Classification
Class II
Status
Ongoing
Quantity
2461 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
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.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Software design

Compare all device evidence states

Inspect official wording and provenance

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.

Code information

Software Versions: Software Version V6.0.0 V6.3.2, Release Date 02-Jul-2015 Units: 1) UDI/DI 00732094263213, Serial Numbers: 117240573990, 117360584950; 2) UDI/DI 00732094263237, Serial Numbers: 117500600524, 122410000834; 3) UDI/DI 00732094263336, Serial Numbers: 118110620686; 4) UDI/DI 00732094263374, Serial Numbers: 116520545398, 116520545399, 117050553501, 117050553502, 117170565092, 117170565093, 117170565094, 117170565095, 117170565096, 118090616242, 118090616243, 118170632609, 118170632608, 118100617936, 118100617935, 118100617934, 118340000113, 118340000114, 118340000115, 118340000116, 118340000117, 118340000118, 118340000119, 118450001233, 118450001234, 118450001235, 118450001236, 118450001237, 118450001238, 118450001239, 118450001240, 118450001241, 119330000811, 119330000812, 119330000813, 119330000814, 119330000815, 119330000816, 119330000817, 119330000818, 119330000819, 119330000820, 119330000821, 120010000185, 120010000186, 120010000187, 120010000188, 120010000189, 120110000599, 120110000600, 120110000601, 120110000602, 120110000603, 121050000579, 121050000580, 121410001265, 121410001266, 121410001267, 121410001268, 122460001565, 122460001566, 122460001567, 123370000157, 123370000158; 5) UDI/DI 00732094263381, Serial Numbers: 116160400812, 116160400841, 116160400843, 116160400845, 116400529512, 116400529513, 116400530030, 116400530031, 116400530032, 116450536621, 116450536622; 6) UDI/DI 00732094263398, Serial Numbers: 118110620685, 118210639085; 7) UDI/DI 00732094263411, Serial Numbers: 117290578773; 8) UDI/DI 00732094263428, Serial Numbers: 116120375032, 116120375035, 117060553847, 117120556934, 117120556935, 120330000900, 120360000449, 122360000839, 122490000191, 122490000192; 9) UDI/DI 00732094263435, Serial Numbers: 117310581163; 10) UDI/DI 00732094263626, Serial Numbers: 116170410170; 11) UDI/DI 00732094263671, Serial Numbers: 120050000514; 12) UDI/DI 00732094263879, Serial Numbers: 116500544081, 116500544082, 116500544083, 117050553074, 117050553075, 117050553076, 117380587626, 117380587627, 117460595385, 117460595386, 117460595387, 117460595388, 117460595389, 117460595390, 118090616424, 118090616425, 118090616426, 118170632607, 118170632606, 118100617938, 118100617937, 118460000409, 118460000410, 118460000411, 118460000412, 118460000413, 118460000414, 121050000574, 121050000575, 121050000576, 121050000577, 121050000578, 121110000824, 121110000825, 121110000826, 121110000827, 121110000828, 121110000829, 121110000830, 121110000831, 121110000832, 121110000833, 121110000834, 121110000835, 121110000836, 121170000411, 121170000412, 121170000413, 121170000414, 121170000415, 121170000416, 121170000417, 121240001237, 121240001238, 121370000463, 121370000464, 121370000465, 121370000466, 121370000467, 121410001255, 121410001256, 121410001257, 121410001258, 121410001259, 121410001260, 121410001261, 121410001262, 121410001263, 121410001264, 122460001573, 122460001574, 122460001575, 122460001576, 122460001577, 123030001336, 123030001337, 123030001338, 123030001339, 123030001340, 123030001341, 123030001342, 123030001343, 123030001344, 123030001345, 123030001346, 123030001347, 123200001027, 123200001028, 123200001029, 123200001030, 123200001031, 123200001032, 123250001021, 123250001022, 123250001023, 123250001024, 123250001025, 123250001026, 123280000365, 123280000366, 123280000367, 123280000368, 123280000369, 123280000370, 123370000153, 123370000154, 123370000155, 123370000156, 123480000934, 123480000935, 123480000936, 121370000466, 124110000985, 124160001082, 124160001083, 124160002095, 124160002096, 124160002097, 124160002098, 124160002099, 124160002100, 124160002101, 124160002102, 124160002103, 124160002104, 124160002105, 124160002106, 124160002107, 124160002108, 124160002109, 124160002110, 124160002111, 124160002112, 124160002113, 124160002114; 13) UDI/DI 00732094263893, Serial Numbers: 118070613221, 120390000393, 122240001151; 14) UDI/DI 00732094263930, Serial Numbers: 116150390528; 15) UDI/DI 00732094263947, Serial Numbers: 115510284680, 115510284694, 119240000738; 16) UDI/DI 00732094289169, Serial Numbers: 118290001244, 118460002309, 118480000818; 17) UDI/DI 00732094296273, Serial Numbers: 118380000431; 18) UDI/DI 00732094308426, Serial Numbers: 122480001104, 123270000832; 19) UDI/DI 00732094309645, Serial Numbers: 119080001407, 119080001408; 20) UDI/DI 00732094312898, Serial Numbers: 119470002281, 119470002281; 21) UDI/DI 00732094312904, Serial Numbers: 121400000049, 121400000050, 121400000051; 22) UDI/DI 00732094312928, Serial Numbers: 122360000843, 122370001541, 122370001542, 123460001117, 123460001118, 123430001428, 123430001429, 123460001117; 23) UDI/DI 00732094312942, Serial Numbers: 120030000547, 120030000548, 120180000461, 120180000462, 120180000463, 120180000464, 120180000465, 120180000466, 120180000467, 120180000468, 120180000463; 24) UDI/DI 00732094312966, Serial Numbers: 119100000503, 119350002685; 25) UDI/DI 00732094315660, Serial Numbers: 119140000184, 119270000109, 119270000110, 120110000692, 120110000693, 120300000079, 121340000884; 26) UDI/DI 00732094318029, Serial Numbers: 123130002242, 123480000937, 123480000937, 124240000223; 27) UDI/DI 00732094318432, Serial Numbers: 120050000646, 120050000647, 120050000648, 120050000649, 120050000650; 28) UDI/DI 00732094321029, Serial Numbers: 119260000098; 29) UDI/DI 00732094323726, Serial Numbers: 119320000899; 30) UDI/DI 00732094326604, Serial Numbers: 119470001903; 31) UDI/DI 00732094336054, Serial Numbers: 120210000789, 121400000901, 121400000902, 122190000640, 122190000641, 122350000278, 122350000279, 123170000266, 123260000923, 123260000924, 10073209433605400, 124110000987, 124250000729; 32) UDI/DI 00732094336061, Serial Numbers: 120210000797, 120210000798, 120210000792, 120210000791, 120210000795, 122290000259, 122290000260, 122290000261, 122290000262, 122380000700, 122380000701, 122460000204, 122460000205, 122460000206, 122500001005, 123270000162, 123270000163, 123270000164, 123270000165, 123280001082, 123490000968, 123490000969, 123500002175, 124200000067, 124200000068, 124200000069; 33) UDI/DI 00732094343786, Serial Numbers: 120520000671, 120520000672, 120520000673, 120520000674, 120520000675, 120520000676, 120520000677, 121040000860, 121040000861, 121040000862, 121040000863, 121040000864, 121040000865, 121040000866, 121040000867, 121040000868, 121040000869, 121040000870, 121040000871, 121040000872, 121040000873, 121040000874, 121040000875, 121040000876, 121040000877, 121040000878, 121040000879, 121050000573, 122020001206, 122020001207, 122020001208, 122020001209, 122020001210, 122020001211, 123280000372, 0, 122020001206, 124100001853, 124100001854, 124100001855, 124220001281, 124280000769; 34) UDI/DI 00732094352672, Serial Numbers: 122310001547; 35) UDI/DI 00812345027563, Serial Numbers: 116070311290, 116070311292, 116070311294, 116100332892, 116130382051, 116130376108, 116140389082, 116140388756, 116170410169, 116180416553, 116180416555, 116190431282, 116210444330, 116230450214, 116230450216, 116240477304, 116240477860, 116240477862, 116240477864, 116240477867, 116240477869, 116240477871, 116230455570, 116230455572, 116230455574, 116230455576, 116230455578, 116230455580, 116230455582, 116230455584, 116230455588, 116310520897, 116310520898, 116230455586, 116310520896, 116320521690, 116320521865, 116330522902, 116330522848, 116330522849, 116340523648, 116350524130, 116370526975, 116400529514, 116400529515, 116400529516, 116400529517, 116400529518, 116390529090, 116370526974, 116400529519, 116400529520, 116400529521, 116400529522, 116400529523, 116400529920, 116400529921, 116400530088, 116400530553, 116400530028, 116420531722, 116420532142, 116430534054, 116430534055, 116450536077, 116450536208, 116460537576, 116460538355, 116460537453, 116470539394, 116490542247, 116490542248, 116510544247, 116510545330, 116510545331, 116520546402, 116520546401, 116520546230, 116520546403, 116520546400, 117050553073, 117060553950, 117080555092, 117090555749, 117090555843, 117090555865, 117090555866, 117090555867, 117110556362, 117110556363, 117110556289, 117110556290, 117120556937, 117120557454, 117120557458, 117120557459, 117120557460, 117130560125, 117130560428, 117130560970, 117140562012, 117150562725, 117140562010, 117140562011, 117150562893, 117160564733, 117170565765, 118210000029, 118210000030, 117200568387, 117200568404, 117190568245, 117190568246, 117190568247, 117190568248, 117190568249, 117200568664, 117200568665, 117200568666, 117210570494, 117220571853, 117220571854, 117220571855, 117220571856, 117240573477, 117250575043, 117250574851, 117260576250, 117290578774, 117290579353, 117300579812, 117300579810, 117320581838, 117310581538, 117330582979, 117350583853, 117350583854, 117340583699, 117350583855, 117340583702, 117350584009, 117350584025, 117350584041, 117350584042, 117350584043, 117360584752, 117360585080, 117370585583, 117380586304, 117380586303, 117380587697, 117380587478, 117380587698, 117410589631, 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124260000416, 124260000417, 124260000771, 124260000772, 124260000773, 124260000774; 36) UDI/DI 00812345027570, Serial Numbers: 116070306098, 116070307281, 116070311291, 116110360656, 116110360658, 116110360660, 116190428764, 116190431265, 116190431268, 116190431239, 116190431241, 116210440023, 116220447275, 116250485174, 116250485959, 116260491968, 116260491970, 116260491972, 116260491974, 116280504761, 116280504768, 116290516786, 116290516812, 116290516813, 116290516815, 116280506964, 116280506966, 116300519873, 116320522168, 116330523070, 116340523725, 116340523726, 116340523727, 116340523728, 116350524962, 116370526231, 116370526235, 116380527225, 116380528397, 116380528398, 116380528399, 116380528400, 116390529085, 116390529086, 116390529087, 116400530261, 116410531492, 116410531499, 116420532365, 116440535274, 116440535550, 116450536751, 116460537578, 116460537579, 116490541737, 116460537577, 116500542854, 116500542855, 116500543269, 116510545083, 116530546706, 116530547125, 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118390000401, 118400000212, 118400000213, 118420000444, 118420000445, 118450000914, 118450000915, 118460002307, 118480000811, 118480000812, 118480000813, 118490000215, 118490000216, 118520000469, 119030000098, 119060000834, 119070000043, 119090001179, 119100000457, 119120000287, 119120001590, 119120001591, 119160000320, 119190000655, 119220000831, 119230002432, 119230002433, 119240000162, 119240000163, 119240000739, 119250000556, 119250000557, 119250000558, 119260000972, 119260000973, 119260000974, 119260000975, 119260000976, 119260000977, 119260001787, 119260001788, 119260001789, 119270000453, 119280000608, 119280000609, 119290000534, 119290000601, 119300000175, 119330000158, 119330000159, 119330000810, 119350002908, 119350002909, 119380001374, 116300519874, 116300519875, 116300519876, 119420001080, 119420001081, 119420001082, 119420001083, 119460000136, 119460000137, 119460000138, 119460001074, 119460001075, 119470000521, 119470000522, 119470001904, 119470001905, 119470001906, 119480000259, 119480000260, 180, 119500001102, 119500001103, 119500001104, 119520000619, 119520000620, 120020001162, 120050000516, 120060000648, 120070001212, 120070001213, 120070001214, 120070001215, 120070001216, 120070001217, 120080002241, 120080002242, 120110001828, 120110001829, 120110001830, 120130000348, 120130000349, 120130001386, 120130001387, 120140001041, 120140001042, 120140001043, 120140002514, 120140002515, 120160001500, 120160001501, 120160001502, 120160001503, 120160001504, 120160001505, 120180001098, 120180001099, 120180001100, 120180001101, 120310001596, 120310001597, 120310001598, 120360001242, 120360001243, 120360001244, 120360001245, 120380000309, 120380000310, 120390000394, 120390001597, 120390001598, 120400001334, 120400001335, 120410000592, 120410001054, 120410001292, 120410001293, 120410001294, 120410001295, 120410001296, 120450000602, 120460000684, 120460000685, 120460000686, 120460002793, 120460002794, 120470000599, 120480000005, 120480000006, 120480000007, 120490001517, 120490001518, 120490001519, 120490001520, 120490001521, 120490001522, 120490001523, 120490001524, 120490003111, 121030000755, 121030000756, 121070000464, 121070002513, 121070002514, 121090001937, 121090001938, 121090001939, 121090001940, 121120000018, 121120000019, 121120000020, 121120000021, 121120000022, 121140000280, 121140000281, 121140000282, 121160001418, 121160001419, 121190000939, 121200000017, 121200000018, 121230000160, 121230000161, 121230002023, 121240000675, 121240000676, 121240000677, 121300001874, 121310001142, 12130001679, 121330001320, 121360001298, 121360001299, 121360001300, 121360001301, 121360001302, 121390002096, 121390002097, 121390002098, 121400000055, 121400001921, 121400001922, 121400001923, 121420000476, 121430000259, 121450000280, 121450001401, 121460001164, 121480000753, 121480000754, 121500000287, 121500000288, 121500000289, 121500000290, 121500000291, 121500000292, 121510001474, 121510001475, 121520000976, 121520000977, 121520000978, 121520000979, 121520000980, 121520000981, 121520001607, 121520001608, 122010001005, 122010001006, 122010001007, 122010001008, 122020000513, 122020001900, 122020001901, 122020001902, 122020001903, 122040000642, 122040000643, 122050001244, 122050001245, 122050001246, 122050001247, 122070001238, 122070001239, 122070001240, 122070001241, 122070001242, 122250000648, 122250000649, 122250000650, 122250000651, 122250000652, 122250000653, 122250000654, 122250000655, 122250000656, 122260000886, 122290001134, 122290001135, 122290001136, 122290001137, 122290001138, 122310001545, 122310001546, 122320000462, 122350000276, 122350000277, 122360000423, 122360000424, 122370000068, 122370000069, 122370000070, 122430000183, 122450000618, 122450000619, 122480002103, 122480002104, 122480002105, 122480002106, 122490000194, 122490000195, 122490000196, 122490000197, 122490000198, 122490000199, 122500001002, 122500001003, 122500001004, 122510000167, 123010000259, 123010000260, 123010000261, 123010000262, 123010000263, 123030001333, 123030001334, 123030001335, 123050001345, 123050001346, 123050001347, 123050001348, 123070000719, 123090001294, 123100001960, 123100001961, 123100001962, 123100001963, 123100001964, 123170000267, 123180000488, 123180000489, 123210000350, 123210000351, 123250000059, 123250000060, 123250000061, 123250000062, 123250000063, 123250000064, 123250001027, 123260000226, 123270000161, 123270001064, 123270001065, 123270001066, 123270001067, 123270001068, 123270001069, 123270001070, 123270001071, 123280000373, 123280000374, 123280000375, 123290000582, 123290000583, 123290000584, 123300001832, 123300001833, 123300001834, 123310001376, 123

Distribution pattern

Worldwide distribution.

device · product 3 of 6

Hillrom Welch Allyn RScribe 12-Lead Electrocardiograph System; Electrocardiograph

Z-0322-2025
Recall number
Z-0322-2025
Initiated
October 11, 2024
Classification
Class II
Status
Ongoing
Quantity
399 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
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.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Software design

Compare all device evidence states

Inspect official wording and provenance

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.

Code information

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

Distribution pattern

Worldwide distribution.

device · product 4 of 6

Hillrom Welch Allyn Vision Express Holter Analysis System; Electrocardiograph

Z-0323-2025
Recall number
Z-0323-2025
Initiated
October 11, 2024
Classification
Class II
Status
Ongoing
Quantity
1003 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
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.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Software design

Compare all device evidence states

Inspect official wording and provenance

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.

Code information

Software Versions: Software Version V6.1.0 - V6.4.1, Release Date 02-Aug-2016 Units: 1) UDI/DI 00732094261301, Serial Numbers: 116400529526, 116410531595, 116420531929, 116420532394, 116440534958, 116440534959, 116440534960, 116500543068, 116510544188, 116510544192, 116510544191; 2) UDI/DI 00812345027051, Serial Numbers: 116410531060, 117210570806, 115240259136, 115350270162, 115530286838, 116130382969, 116410531059, 117010548786, 117160563990, 118090615607, 118130624377, 115260260785, 115310266618, 115280263535, 115370271720, 115390273747, 115390273748, 115410276165, 115430277859, 115460280004, 116050290951, 116100343595, 116110348130, 116110348131, 116170409317, 116220446115, 116330522729, 116330523086, 116350524579, 116350524580, 116350524581, 116350524582, 116350524853, 116420531720, 116430533397, 116430533398, 116440535530, 116350524071, 116490541748, 116490541749, 117250575051, 117250575363, 117250575364, 117340583722, 117410590078, 117430592084, 117500601366, 118090616236, 118160629028, 118140625595, 118160629029, 118330000135, 118410000001, 118410000002, 118460000097, 118480000460, 118480000461, 118480000462, 118490001240, 119020000445, 119020000446, 119060000053, 119060000054, 119070001052, 119070001053, 119230002856, 119340000158, 119370000057, 119370000058, 119370000178, 119370001496, 119370001497, 119370001498, 119460000833, 119500001339, 120020000988, 120100000089, 120280000432, 120320001228, 120440000892, 120510002432, 121100000101, 121110000861, 121110000862, 121110000863, 121230001319, 121240000969, 121240000970, 121240000971, 121290000849, 121290000850, 121290000851, 121290000852, 121500000118, 121500000119, 121500000120, 122090000845, 122090000846, 122090000847, 122120000811, 122120000812, 122120000813, 122120000814, 122120000815, 122120000816, 122150000719, 122150000720, 122150000721, 122150000722, 122150000723, 122150000724, 122150000725, 122150000726, 122150000727, 122150000728, 122230001110, 122230001111, 122250000399, 122260000144, 122260000145, 122260000146, 122260000147, 122260000148, 122280001208, 122280001209, 122280001210, 122280001211, 122400001837, 122400001838, 122400001839, 123010000049, 123010000050, 123010000051, 123010000052, 123010000053, 123010000054, 123010000055, 123320000199, 123320000200, 123450000561, 123160002031, 123160002033, 123300001539, 123300001542, 123520000112, 123520000113, 123520000114, 123520000115, 10081234502705100, 122150000724, 122400001838, 123010000049, 123010000052, 123010000054, 123320000199, 124130001623, 124180000490, 124260001347; 3) UDI/DI00812345027068, Serial Numbers: 115110248137, 115120250168, 115120250169, 115120250835, 115300266105, 115320267445, 115350270310, 115390274014, 115410276436, 115430277751, 116030288867, 116050291028, 116100343594, 116160400312, 116170411681, 116270498880, 116270498881, 116290510913, 116310521392, 116330522476, 116330522846, 116360525666, 116380527662, 116380527663, 116380527664, 116380527665, 116380527666, 116380527667, 116400529602, 116420532353, 116510544289, 116510545147, 116510545159, 116510545158, 117140561179, 117150562724, 117160564171, 117160564172, 117170566155, 117180566532, 117180566934, 117190568193, 117250575344, 117310581639, 117310581640, 117310581638, 117310581641, 117310581642, 117440593357, 117490599735, 117490599734, 117500600817, 117500600819, 117500600818, 117490599736, 117510602844, 118200638054, 118190635525, 118190635527, 118180633949, 118170632206, 118160628146, 118160628147, 118160628148, 118150627467, 118110619514, 118120622404, 118180633948, 118200638055, 118190635526, 118250001330, 118250001331, BURV53H-1, 118270000668, 118280001091, 118280001092, 118330000136, 118370000761, 118370001398, 118440001535, 118480000809, 118490001241, 118490001242, 119080000826, 119080000827, 119080000828, 119140001055, 119140001092, 119180000771, 119180001177, 119190000969, 119200000579, 119240000465, 119330000325, 119420001704, 119440000373, 119440000374, 119460000834, 119460000835, 119460000836, 119440000475, 119490000290, 119490000291, 119490000292, 119490000293, 119490000294, 119490000295, 119490000296, 119490000297, 119500000520, 119500000521, 119500000522, 119500000523, 119500000524, 119510001622, 119510001623, 119510001624, 119510001625, 119510001626, 120060000448, 120060000449, 120080000872, 120080000873, 120090001018, 120090001019, 120240001638, 120240001639, 120240001640, 120290001161, 120350001776, 120350001777, 120350001778, 1194200017041, 120470000519, 120470000520, 120470000521, 120470000522, 121040002265, 121040002266, 121070002239, 121070002240, 121070002241, 121110000497, 121110000498, 121160001131, 121160001132, 121160001133, 121200000777, 121200000778, 121200000779, 121200000780, 121200000781, 121200000782, 121200000783, 121310001223, 121310001224, 121310001225, 121310001226, 121310001227, 121200000784, 121410000786, 121410000787, 121410000788, 121410000789, 121460000046, 121460000047, 121460000048, 121460000049, 121460000050, 122050001031, 122050001032, 122050001033, 122050001034, 122170001361, 122190001148, 122190001149, 122190001150, 122190001151, 122420001054, 122420001055, 122420001056, 122420001057, 123010000479, 123010000480, 123010000481, 123010000482, 123150001361, 123150001362, 123240000024, 123240000025, 123350000443, 123360001857, 123380000670, 123380000671, 121310001225, 124110000962, 124230001402, 124230001403, 124280000318, 124320000515; 4) UDI/DI 00812345027075, Serial Numbers: 115110249707, 115110249708, 115130251591, 115130251592, 115130251593, 115130251594, 115130251595, 115130251596, 115130251597, 115130251598, 115130251599, 115130251600, 115130251601, 115150252703, 115210257523, 115210257512, 115220257782, 115280264212, 115300265573, 115300265777, 115310266138, 115310266124, 115310266216, 115310266655, 115320268102, 115370271878, 115410275610, 115420277047, 115440278420, 115510285228, 115500284465, 116040288873, 116030288807, 116050290952, 116060301719, 116070309917, 116090323664, 116090330859, 116120374781, 116130382238, 116130383028, 116170408045, 116170411682, 116200435246, 116210440263, 116240477780, 116290511737, 116310521391, 116330522847, 116350525036, 116350525037, 116360525872, 116360526094, 116410531590, 116420532605, 116430533949, 116440535188, 116440535278, 116440535279, 116450535997, 116450535996, 116450536230, 116450536231, 116460538407, 116460538406, 116480540876, 116480540877, 116510545160, 116500542933, 116500542932, 116500542931, 116520545424, 116520545425, 116520545426, 116530546785, 117010548783, 117020550456, 117030550902, 117030551203, 117080554884, 117110556369, 117140561177, 117120556618, 117160563863, 117190567087, 117190567088, 117310581634, 117310581635, 117310581208, 117310581633, 117310581636, 117310581637, 117350583997, 117370586270, 117370586268, 117370586269, 117390588138, 117410589759, 117430591674, 117440593350, 117440593351, 117440593352, 117440593353, 117440593354, 117460594802, 117460594803, 117500600825, 117500600824, 117500600827, 117510602911, 117500600826, 118030607284, 118030607285, 118030607286, 118030607287, 118090616237, 118110620972, 118170631076, 118170631074, 118150627953, 118130624754, 118130624107, 118170631075, 118180634463, 118200636949, 118200636948, 118170631077, 118180634462, 118170631078, 118380001914, 118380001915, 118380001916, 118380001917, 118400000248, 118400000249, 118460001722, 118460002304, 118480000463, 118500002156, 118500002157, 118520000565, 118520000566, 118520000567, BURV53H-2, 119020000192, 119020000193, 119020000194, 119120001137, 119160000049, 119160000334, 119170000207, 119180000552, 119180000553, 119200000364, 119200000365, 119200001809, 119200001810, 119250001367, 119340001025, 119340001026, 119340002117, 119350003153, 119370000056, 119400000246, 119420001705, 119440000375, 119440000376, 119460000837, 119490001497, 119500000525, 119500000526, 119510000326, 119510000327, 119510000328, 119510001620, 119510001621, 120020000989, 120030000044, 120030000045, 120030000046, 120030000047, 120030000048, 120030000049, 120030000050, 120030000051, 120030000052, 120030000053, 120030000054, 120030000055, 120030000056, 120030000057, 120030000058, 120080000431, 120080000432, 120080000433, 120080000434, 120080000435, 120090001016, 120090001017, 120100002170, 120110000524, 120110000525, 120110000526, 120120001189, 120120001190, 120120001191, 120190000362, 120190000363, 120220000680, 120220000681, 120220000682, 120240003121, 120240003122, 120240003123, 120270001111, 120270001112, 120270001113, 120300000455, 120300000456, 120300000457, 120320001225, 120320001226, 120320001227, 120400001718, 120400001719, 120400001720, 120410000778, 120410000779, 120410000780, 120410000781, 120410000782, 120410000783, 120410000784, 120470000523, 120470000524, 120470000525, 120500000172, 120500000173, 120500000174, 120530000350, 120530000351, 120530000352, 120530000353, 120530000354, 121030000750, 121030000751, 121030000752, 121030000753, 121030000754, 121070000631, 121070000632, 121070000633, 121110000499, 121110000500, 121160001879, 121160001880, 121160001881, 121160001882, 121170001049, 121170001050, 121170001051, 121220000291, 121220000292, 121220000293, 121220000294, 121300001842, 121300001843, 121300001844, 121300001845, 121380000077, 121380000078, 121380000079, 121380000080, 121450000995, 121450000996, 121450000997, 121450000998, 121510000512, 121510000513, 121510000514, 121510000515, 122060002262, 122060002263, 122060002264, 122060002265, 122060002266, 122140001058, 122140001059, 122140001060, 122140001061, 122170001923, 122170001924, 122180000431, 122180000432, 122180000433, 122230001112, 122260001770, 122280001207, 122330001127, 122330001128, 122330001129, 122350000265, 122350000266, 122350000267, 122350001404, 122350001405, 122350001406, 122350001407, 122400000503, 122400000504, 122400000505, 122400000506, 122510001081, 122510001082, 122510001083, 122510001084, 123030001920, 123030001921, 123030001922, 123140001156, 123140001157, 123150001359, 123150001360, 123210000712, 123210000713, 123370001081, 123370001082, 123400000067, 123500000575, 123500000576, 124070000638, 10081234502707500, 116360525872, 120270001113, 121450000995, 123500000575, 124110001734, 124160001407, 124160001408, 124190001170, 124290002021, 124310000354; 5) UDI/DI 00812345027082, Serial Numbers: 115140252371, 115180255199, 115200256450, 115200256484, 115170254607, 115240259273, 115270262436, 115270262455, 115270262556, 115280264204, 115280264328, 115440278240, 115390274074, 115500283203, 115490282596, 115520286030, 115500283938, 115510285075, 116030288752, 116040289702, 116050290280, 116100346578, 116110349503, 116110361053, 116120364554, 116130376068, 116160401959, 116170409316, 116170411679, 116190428778, 116190431104, 116230449929, 116260495851, 116330522475, 116340523672, 116360526095, 116370527085, 116400530262, 116410531591, 116430533997, 116440535238, 116440535239, 116450536627, 116450536638, 116460538289, 116460538288, 116470539397, 116470539537, 116470539536, 116470539538, 116490541861, 116510544316, 116510544315, 116510545146, 116520545930, 116520545583, 116530547264, 116520545584, 116520546523, 116520546524, 116520546525, 116520546526, 117010548782, 117030551389, 117050552695, 117060553949, 117080555399, 117080555400, 117080555401, 117080555402, 117120557407, 117160563416, 117200569215, 117200569175, 117260575944, 117290578819, 117300580773, 117380586613, 117410589508, 117440593355, 117450593975, 117440593356, 117500600695, 117490600177, 117490600178, 117490600179, 117500600821, 117500600820, 117500600822, 117520603563, 117500600823, 118030607413, 118040608358, 118040608359, 118050609181, 118090615605, 118090615606, 118100617441, 118110619513, 118160628065, 118170631081, 118140625598, 118120622405, 118180634461, 118170631079, 118250002095, 118250002096, BURV53H-5, 118170631080, 118180634458, 118180634459, 118340000885, 118340000886, 118350000095, 118350000733, 118360000338, 118360000339, 118360000340, 118370001517, 118410000877, 118490000196, 118490000197, 118510000328, 118520000568, 119020000195, 119020000196, 119050000263, 119050000264, 119050000265, 119090000535, 119090000536, 119090000960, 119090000961, 119090000962, 119090000963, 119090000964, 119190000649, 119220000921, 119240000118, 118180634460, 119250000549, 119250001366, 119310000503, 119310000946, 119310000947, 119330001331, 119360000491, 119360000492, 119370001499, 119370001500, 119370001501, 119370001502, 119400000247, 119400001340, 119420001706, 119440000377, 119440000378, 119460000838, 119460000839, 119470001614, 119500000527, 119500001338, 119510000329, 119510000330, 119510001627, 119510001628, 119510001629, 120010000542, 120010000543, 120020000990, 120020000991, 120020000992, 120030000198, 120040000418, 120040000419, 120040000420, 120040000421, 120040001017, 120040001018, 120040001019, 120040001020, 120040001021, 120050001927, 120050001928, 120050001929, 120050001930, 120050001931, 120080000426, 120080000427, 120080000428, 120080000429, 120080000430, 12004000119, 12004000120, 12004000121, 12004000122, 12004000123, 12004000421, 120110001205, 120110001206, 120140000809, 120230001258, 120230001259, 120250000045, 120250000046, 120280000900, 120310000836, 120310000837, 120310000838, 120330000710, 120330000711, 120330000712, 120350001779, 120350001780, 120350001781, 120450001898, 120450001899, 120450001900, 10081234502708200, 120490000363, 120490000364, 120490000365, 120510001850, 120510001851, 120510001852, 120510001853, 120510001854, 121110000493, 121110000494, 121110000495, 121110000496, 121150000404, 121150000405, 121150000406, 121200000785, 121200000786, 121200000787, 121280000695, 121280000696, 121280000697, 121340000506, 121340000507, 121070002239, 121400000479, 121400000480, 121400000481, 121400000482, 121500001371, 121500001372, 121500001373, 121500001374, 122070001107, 122070001108, 122070001109, 122070001110, 122070001111, 122150001051, 122150001052, 122160000458, 122160000459, 122200001101, 122200001102, 122200001103, 122290000600, 122350000268, 122350000269, 122410001383, 122410001384, 122410001385, 122440000484, 122440000485, 122440000486, 122440000487, 122440000488, 123020000506, 123020000507, 123020000508, 123020000509, 123110001383, 123110001384, 123200001549, 123210000714, 123420000261, 123470000003, 10081234502708200, 124040001468, 115140252371, 118360000340, 119460000839, 121340000507, 124010000865, 124040001468

Distribution pattern

Worldwide distribution.

device · product 5 of 6

Hillrom Welch Allyn Diagnostic Cardiology Suite (formerly Connex Cardio); Diagnostic spirometer

Z-0324-2025
Recall number
Z-0324-2025
Initiated
October 11, 2024
Classification
Class II
Status
Ongoing
Quantity
1369 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
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.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Software design

Compare all device evidence states

Inspect official wording and provenance

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.

Code information

Software Versions: Software Version V2.1.0, Release Date 12-Aug-2019 Connex Cardio Software Version V1.0.0 V1.1.1 18-Oct-2017 Units: 1) UDI/DI 00817655022598, Serial Numbers: 117460595592, 117460595593, 117500601372, 117500601373, 117500601374, 117500601375, 118040607879, 118040607880, 118070613199, 117500601376, 118070613204, 118070613205, 118070613206, 118070613207, 118290000487, 118340002360, 118350000586, 118350000874, 118420000133, 118420001242, 118420001243, 118420001244, 118420001245, 118420001246, 118420001247, 118420001248, 118440000341, 118440000343, 118440000344, 118440000345, 118440000346, 118440000347, 118440000348, 118440000349, 118440000350, 118440000351, 118440000352, 118440000353, 118440000354, 118440000355, 118440000416, 118440000417, 118440000418, 118440000419, 118440000420, 118440000421, 118440000422, 118440000423, 118440000424, 118440000425, 118440000426, 118440000427, 118440000428, 118440000429, 118440000430, 118440000431, 118440000432, 118440000433, 118440000434, 118440000435, 118440000436, 118440000437, 118440000438, 118440000439, 118440000440, 118440000441, 118440000442, 118440000443, 118440000444, 118440000445, 118440000446, 118440000447, 118450000095, 91CC-RXX-WADX, 119010000553, 119080000336, 119110000838, 119110000917, 119190001425, 119210001310, 119230003328, 119300000806, 119360000493, 119370000813, 119370001060, 119370001061, 119370001062, 119370001063, 119370001064, 119370001065, 119370001066, 119390000161, 119390000162, 119390000163, 119390000164, 119390000165, 119390000166, 119390000167, 119390000168, 119390000169, 119390000170, 119390000171, 119390000172, 119420001707, 119420001708, 119470002111, 119490001377, 119490001378, 119510000226, 119510000227, 120040000372, 120040000373, 120060000891, 120070000342, 120080000579, 120130000317, 120150001031, 120150001032, 120150001033, 120150001034, 120150001035, 120150001036, 120150001037, 120150001038, 120160001481, 120160001482, 120160001483, 120160001484, 120160001485, 120190000186, 21120160001483, 21120160001482, 21120150001038, 21120150001036, 21120150001035, 120290000212, 120290001229, 120290001230, 120290001231, 120330000274, 120330000275, 120330000276, 120330000515, 120330000755, 120370001216, 120370001217, 120370001218, 120380001098, 120380001099, 120380001100, 120380001101, 120390001503, 120390001504, 120390001505, 120390001506, 120390001507, 120390001508, 120390001509, 120390001510, 120390001511, 120390001512, 21120150001032, 120400002430, 120400002431, 120400002432, 120400002433, 120400002434, 120400002435, 120400002436, 120420002037, 120420002038, 120420002039, 120420002040, 120420002041, 120420002042, 120420002043, 120420002044, 120420002045, WA-C6559529, 120490001358, 120490001359, 120490001360, 120490001361, 120490001362, 120490001363, 120490001364, 120490001365, 120490001366, 120490001367, 120490001368, 120490001369, 120490001370, 120490001371, 120490001372, 120490001373, 120490001374, 120490001375, 120490001376, 120490001377, 120490001378, 120490001379, 120490001380, 120490001381, 120490001382, 120490001383, 120490001384, 120490001385, 120490001386, 120490001387, 120490001388, 120490001389, 120490001390, 120490001391, 120490001392, 120490001393, 21120160001485, 121020000503, 121020000504, 121020000505, 121020000506, 121020000507, 121020000508, 121020000509, 121020000510, 121020000511, 121020000512, 121020000513, 121020000514, 121050000479, 121050000480, 121050000481, 121050000482, 121050000483, 121050000484, 121050000485, 121050000486, 121050000487, 121050000488, 121050001827, 121050001828, 121070000793, 121070000794, 121070000795, 121070000796, 121070000797, 121100000420, 121100000421, 121100000422, 121100000423, 121100000424, 121100000425, 121100000426, 121100000427, 121100000428, 121100000429, 121140000204, 121140000205, 121140000206, 121140000207, 121140000208, 121140000209, 121140000210, 121140000211, 121140000212, 121140000213, 121160000921, 121160000922, 121160000923, 121160000924, 121160000925, 1, 2, 3, 4, 5, 121200000616, 121200000617, 121200000618, 21120390001506, 121210003215, 121240000666, 121240000667, 121240000668, 121240000669, 121260001417, 121260001418, 121260001419, 121260001420, 121270000358, 121270000359, 121270000360, 121270000361, 121270000362, 121310003933, 121320000258, 121320000259, 121320000260, 121320000261, 121320000262, 21120390001510, 121390000721, 121390000722, 121390000723, 121400000303, 121410000471, 121410000472, 121410000473, 121410000474, 121410002140, 121410002141, 121410002142, 121430000246, 121430000247, 121430001551, 121430001552, 121430001553, 121430001554, 121430001555, 121430001556, 121430001557, 121430001558, 121430001559, 121430001560, 121430001561, 121430001562, 121430001563, 121430001564, 121430001565, 121430001566, 121430001567, 121430001568, 121430001569, 121430001570, 121430001571, 121430001572, 121430001573, 121450000264, 121450000265, 121460000630, 121460000631, 121460000632, 121490000541, 122010000426, 122040000372, 122040000373, 122050000134, 122050000135, 122050000136, 122050000137, 122060000560, 122060000561, 122060000562, 122060000563, 122060000564, 122060000565, 122060000566, 122060000567, 122060000568, 122060000569, 122090000487, 122090000488, 122090000489, 122090000490, 122090000491, 122090000492, 122090000493, 122090000494, 122090000495, 122090000496, 122110000747, 122110000748, 122120000253, 122130000774, 122130000775, 122140000180, 122140000181, 122140000182, 122140000183, 122170001935, 122170001936, 122170001937, 122170001938, 122170001939, 122190000570, 122190000571, 122190000572, 122190000573, 122190000574, 122190000575, 122190000576, 122190000577, 122190000578, 122190000579, 122190000580, 122190000581, 122190000582, 122190000583, 122190000584, 122200000636, 122200000637, 122200000638, 122200000639, 122200000640, 122200000642, 122200000643, 122200000644, 122200000645, 10081765502259800, 122250000887, 122250000888, 122250000889, 10081765502259800, 122270000327, 122270000328, 122270000329, 122270001140, 122270001141, 122270001142, 122350000871, 122360000732, 122360000733, 122480000562, 122480000563, 122480000564, 122480000565, 122480000566, 122480000567, 122480000568, 122480000569, 122480000570, 122480000571, 122480000572, 122480000573, 122480000574, 122480000575, 122480000576, 122480000577, 122480000578, 122480000579, 122480000580, 122480000581, 122490001472, 122490001473, 122490001474, 122490001475, 122490001476, 122490001477, 122520000346, 122520000347, 122520000348, 122520000349, 122520000350, 122520000351, 122520000352, 122520000353, 122520000354, 122520000355, 123050001850, 123050001851, 123050001852, 123050001853, 123050001854, 123080000052, 123080000053, 123080000054, 123080000055, 123080000056, 123120000129, 123120000130, 123130001116, 123130001117, 123130001118, 123130001119, 123130001120, 123130002250, 123130002251, 123130002252, 123130002253, 123130002254, 123130002255, 123130002256, 123130002257, 123130002258, 123130002259, 123180000485, 123180000486, 123180000487, 123210000783, 123210000784, 123210000785, 123210000786, 123240000205, 123240000206, 123240000207, 123300002140, 123300002141, 123300002142, 123300002143, 123300002144, 123320000675, 123320000676, 123320000677, 123330000643, 123330000644, 123330000645, 123350000828, 123350000829, 123350000830, 123350000831, 123350000832, 123380000882, 123380000883, 123380000884, 123400000185, 123400000186, 123410000806, 123410000807, 123410000808, 123410000809, 123410000810, 123410000811, 123410000812, 123450000535, 123450000536, 123450000537, 123450000538, 123450000539, 123450000540, 123400005838, 123480000403, 123480000404, 123480000405, 123480000406, 123480000407, 123480000408, 123480000409, 123480000410, 123480000411, 123480000412, 124030000221, 124030000222, 124030000223, 124030000720, 124030000721, 124040000748, 124040000749, 124040000750, 124040000751, 124040000752, 124050001632, 124050001633, 124070000341, 124070000342, 124070000343, 124070000344, 124080001389, 124080001390, 124080001391, 124080001392, 124080001393, 124090000193, 124090000194, 124090000195, 118440000351, 118440000443, 122480000569, 124030000222, 124040000748, 124040000749, 124040000750, 124040000751, 124040000752, 124110000713, 124170001449, 124170001450, 124170001451, 124190000655, 124190000656, 124190000657, 124190000658, 124190000659, 124190000660, 124190000661, 124190000662, 124190000663, 124190000664, 124190000665, 124190000666, 124190000667, 124190000668, 124190000669, 124200000063, 124200002640, 124200002641, 124220000129, 124220000130, 124230001175, 124230001176, 124230001177, 124230001178, 124230001179, 124230001180, 124260000634, 124260000635, 124260000636, 124260000637, 124260000638, 124260000639, 124260000640, 124260000641, 124260000642, 10081765502259800, 124070000340, 124080001389, 124080001390, 124080001391, 124080001392, 124080001393, 124090000193, 124090000194, 124090000195, 124110000713, 124110000714, 124110000715; 2) UDI/DI 00817655022611, Serial Numbers: 118070613209, 118070613210, 118080615506, 118080615507, 118080615508, 118080615509, 118080615510, 118080615511, 118080615512, 118100617237, 118100617238, 118100617239, 118100617240, 118100617241, 118100617242, 118100617243, 118100617244, 118100617245, 118100617246, 118100617247, 118100617249, 118100617250, 118100617251, 118100617252, 118100617253, 118100617254, 118100617255, 118100617256, 118100617257, 118100617258, 118100617259, 118100617260, 118100617261, 118100617262, 118100617263, 118100617264, 118100617265, 118100617266, 118100617267, 118100617268, 118100617269, 118100617270, 118100617271, 118100617272, 118100617273, 118100617274, 118100617248, 118250001251, 118250001252, 118250001255, 118250001256, 118250001257, 118250001258, 118250001259, 118250001260, 118250001261, 118250001262, 118250001263, 118250001264, 118250001265, 118250001266, 118250001267, 118250001268, 118250001269, 118250001270, 118250001271, 118250001272, 118250001273, 118250001274, 118250001275, 118250001276, 118250001277, 118250001278, 118250001279, 118250001280, 118250001281, 118250001282, 118250001283, 118250001284, 118250001285, 118250001286, 118250001287, 118250001288, 118250001289, 118250001290, 118250001291, 118250001292, 118250001293, 118250001294, 118250001295, 118250001296, 118250001297, 118250001298, 118250001299, 118250001300, 10081765502261100, 118290001236, 118290001237, 118390000375, 118390000376, 118390000377, 118390000378, 118390000379, 118460000961, 118250000897, 119100001128, 119100001129, 119100001130, 119100001131, 119100001132, 119100001133, 119100001134, 119100001135, 119100001136, 119100001137, 119100001138, 119100001139, 119100001140, 119170000209, 119170000210, 119210001410, 119210001411, 119210001412, 119210001413, 119210001414, 119210001415, 119210001416, 119210001418, 119210001419, 119210001420, 119210001422, 119210001423, 119210001424, 119210001485, 119210001486, 119210001487, 119210001488, 119210001489, 119210001490, 119210001491, 119210001492, 119210001493, 119210001494, 119210001495, 119210001496, 119210001497, 119210001498, 119210001499, 119210001500, 119230000152, 119500000892, 119500000893, 120150001006, 120150001007, 120150001008, 120150001009, 120150001010, 120150001011, 120150001012, 120150001013, 120240001131, 120240001132, 120240001133, 120240001134, 120240001135, 120240001136, 120240001137, 120240001138, 120240001139, 120240001140, 120240001141, 120240001142, 120240001143, 120240001144, 120240001145, 120240001146, 120240001147, 120240001148, 120240001149, 120240001150, 120240001151, 120240001152, 120240001153, 120240001154, 120240001155, 120240001156, 120240001157, 120240001158, 120240001159, 120240001160, 120240001191, 120240001192, 120240001193, 120240001194, 120240001195, 120240001196, 120240001197, 120240001198, 120240001199, 120240001200, 120240001201, 120240001202, 120240001203, 120240001204, 120240001205, 120240001206, 120240001207, 120240001208, 120240001209, 120240001210, 120240001211, 120240001212, 120240001213, 120240001214, 120240001215, 120240001216, 120240001217, 120240001218, 120240001219, 120240001220, 120240002422, 120240002423, 120240002424, 120260000956, 120260000957, 120270001366, 120270001367, 120270001368, 120270001369, 120270001370, 120270001371, 21120150001008, 120380001857, 120380001860, 120380001861, 120380001862, 120380001863, 120380001864, 120380001865, 120380001866, 120380001867, 120380001868, 120380001869, 120380001870, 120380001871, 120390001451, 120390001452, 120390001453, 120390001454, 120390001455, 120390001456, 120390001457, 120390001458, 120390001459, 120390001460, 120390001461, 120390001462, 120390001463, 120390001464, 120390001465, 120390001466, 120390001467, 120390001468, 120390001469, 120390001470, 120410001194, 120410001195, 120410001196, 120410001197, 120410001198, 120410001199, 120410001200, 120410001201, 120410001202, 120410001203, 120410001204, 120410001205, 120410001206, 120470000113, 120510002156, 120510002157, 120510002158, 120510002159, 120510002160, 120510002161, 120510002162, 120510002163, 120510002164, 120510002165, 120510002166, 121010000489, 121010000490, 121010000491, 121010000492, 121010000493, 121010000494, 121010000495, 121120001733, 121120001734, 121150000332, 121150000333, 121150000334, 121150000335, 121150000336, 121150000337, 121150000338, 121150000339, 121150000340, 121150000341, 121150000342, 121150000343, 121150000344, 121150000345, 121150000346, 121150000347, 121150000348, 121150000349, 121150000350, 121150000351, 121150000352, 121180000583, 121180000584, 121180000585, 121180000586, 121180000587, 121180000588, 121180000589, 121180000590, 121180000591, 121180000592, 121180000777, 121180000778, 121180000779, 121180000780, 121180000781, 121180000782, 121180000783, 121180000784, 121180000785, 121180000786, 121180000787, 121180000788, 121180000789, 121180000790, 121180000791, 121180000792, 121180000793, 121180000794, 121180000795, 121180000796, 121180000797, 121180000798, 121180000799, 121180000800, 121180000801, 121180000802, 121180000803, 121180000804, 121180000805, 121180000806, 121260000563, 121260000564, 121260000565, 121260000566, 121260000567, 121260000568, 121280002245, 121280002246, 10081765502261100, 121340001393, 121340001394, 121360000181, 121380000264, 121390000714, 121400000256, 121410000382, 121410000383, 121410000384, 121410000385, 121410000386, 121410000387, 121410000388, 121410000389, 121410000390, 121410000391, 121410000392, 121410000393, 121410000394, 121410000395, 121410000396, 121410000397, 121410000398, 121410000399, 121410000400, 121410000401, 121410000402, 121410000403, 121410000404, 121410000405, 121410000406, 121410000407, 121410000408, 121410000409, 121410000410, 121410000411, 121410000412, 121410000413, 121410000414, 121410000415, 121410000416, 121410000417, 121410000418, 121410000419, 121410000420, 121410000421, 121410000422, 121410000423, 121410000424, 121410000425, 121410000426, 121410000427, 121410002126, 121410002127, 121410002128, 121410002129, 121430000240, 121430000241, 121430000242, 121430000243, 121430000244, 121430000245, 121440000099, 121440000100, 121440000101, 121440000102, 121440000103, 121500000187, 122030000768, 122030000769, 122030000770, 122030000771, 122030000772, 122130000758, 122130000759, 122130000760, 122130000761, 122130000762, 122130000763, 122130000764, 122130000765, 122140000167, 122140000168, 122140000169, 122180001491, 122180001492, 122180001493, 122180001494, 122180001495, 122180001496, 122180001497, 122180001498, 122180001499, 122180001500, 122180001501, 122180001502, 122180001503, 122180001504, 122180001505, 122180001506, 122180001507, 122180001508, 122180001509, 122180001510, 122180001511, 122180001512, 122180001513, 122180001514, 122180001515, 122200000626, 122200000627, 122200000628, 122200000629, 122200000630, 122200000631, 122200000632, 122200000633, 122200000634, 122200000635, 122200001846, 122200001847, 122200001848, 122200001849, 122200001850, 122200001851, 122200001852, 122200001853, 122200001854, 122200001855, 122200001856, 122200001857, 122200001858, 122200001859, 122200001860, 122240000722, 122240000723, 122240000724, 122240000725, 122240000726, 122240000727, 122240000728, 122240000729, 122240000730, 122240000731, 122240000732, 122240000733, 122240000734, 122240000735, 122240000736, 122240000737, 122250001092, 122250001093, 122250001094, 122250001095, 122250001096, 122250001097, 122250001098, 122250001099, 122250001100, 122250001101, 122250001102, 122250001103, 122250001104, 122250001105, 122250001106, 122250001107, 122250001108, 122250001109, 122250001110, 122250001111, 122250001112, 122250001113, 122250001114, 122250001115, 122250001116, 122250001117, 122250001118, 122250001119, 122250001120, 122250001121, 122250001122, 122250001123, 122250001124, 122250001125, 122250001126, 122250001127, 122250001128, 122250001129, 122250001130, 122250001131, 122250001132, 122250001133, 122250001134, 122250001135, 122250001136, 122250001137, 122250001138, 122250001139, 122250001140, 122250001141, 122250001142, 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122500000629, 122520000316, 122520000317, 122520000318, 122520000319, 122520000320, 122520000321, 122520000322, 122520000323, 122520000324, 122520000325, 123040001202, 123040001203, 123040001204, 123040001205, 123040001206, 123080000047, 123080000048, 123080000049, 123080000050, 123080000051, 123130002245, 123130002246, 123130002247, 123130002248, 123130002249, 123170000104, 123170000105, 123180001889, 123180001890, 123180001891, 123180001892, 123180001893, 123280000084, 123280000085, 123280000086, 123280000087, UNKNOWN, 123330000948, 123330000949, 123330000950, 123330000951, 123330000952, 123350000803, 123350000804, 123350000805, 123350000806, 123350000807, 123360001860, 123360001861, 123360001862, 123360001863, 123360001864, 123370001189, 123370001190, 123370001191, 123370001192, 123370001193, 123370001194, 123370001195, 123370001196, 123370001197, 123370001198, 123400001281, 123400001282, 123400001283, 123500002178, 123500002179, 124010000233, 124010000234, 124060000797, 120240001137, 120240001157, 121150000345, 124160001011, 124160001012, 124160002115, 124160002116, 124160002117, 124190000639, 124190001210, 124190001211, 124260000630, 124260000631, 124260000632, 124260000633, 124290000159, 124290002125, 124310000385, 124310000386, 124310000387, 124310002758, 124310002759, 124310002760, 10081765502261100, 10081765502261100, 124090001025, 124090001026, 124100001968, 124100001969, 124140001142, 124160001011, 124160001012, 124160001013,

Distribution pattern

Worldwide distribution.

device · product 6 of 6

Hillrom Welch Allyn XScribe Cardiac Stress Testing System; Programmable Diagnostic Computer

Z-0325-2025
Recall number
Z-0325-2025
Initiated
October 11, 2024
Classification
Class II
Status
Ongoing
Quantity
766 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
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.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Software design

Compare all device evidence states

Inspect official wording and provenance

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.

Code information

Software Versions: Software Version V6.0.0 V6.3.2, Release Date 02-Jul-2015 Units: 1) UDI/DI 00732094259032, Serial Numbers: 115340269178, 117060553883, 117060553884, 117060553885, 119230003169; 2) UDI/DI 00732094259070, Serial Numbers: 117130559202, 117130559203, 117130559204; 3) UDI/DI 00732094259100, Serial Numbers: 116270497046, 117190567440; 4) UDI/DI 00732094259148, Serial Numbers: 117350583961, 119060000843, 122090000529; 5) UDI/DI 00732094259179, Serial Numbers: 116240458434, 116500543985, 120480000930; 6) UDI/DI 00732094259230, Serial Numbers: 118160628177; 7) UDI/DI 00732094259261, Serial Numbers: 117470596306; 8) UDI/DI 00732094259285, Serial Numbers: 118100618358, 116110348774, 116490541753, 117430591185, 117510601740; 9) UDI/DI 00732094259292, Serial Numbers: 116460537153, 118490000226; 10) UDI/DI 00732094259308, Serial Numbers: 116120365527, 119410001349, 119410001350, 119410001351, 119410001352, 119410001353, 119410001354, 119410001355, 119410001356, 119410001357, 119410001358, 119410001359, 119410001360, 119410001361, 119410001362, 119410001363, 119410001364, 119410001365, 119410001366, 119410001367, 119410001368, 119410001369, 119410001370; 11) UDI/DI 00732094259315, Serial Numbers: 117130559201; 12) UDI/DI 00732094259322, Serial Numbers: 117350583998, 117500601523; 13) UDI/DI 00732094259346, Serial Numbers: 116110347146, 116110347144; 14) UDI/DI 00732094259445, Serial Numbers: 116430533831, 116430533832; 15) UDI/DI 00732094259506, Serial Numbers: 116380527134, 117410589558, 118250001761, 119040000115, 119060000844, 119060000845, 123190000729, 123280000483, 123310000806, 123310000807, 123310000808, 123310000809, 123310000810, 123310000811, 123310000812, 123310000813, 123310000814, 123310000815, 123360000284, 123360000285, 123450001526, 123310000809, 123310000811, 123310000812, 123310000815; 16) UDI/DI 00732094259575, Serial Numbers: 118250001384, 118260000794, 118390001821, 118480000848, 118480000849, 119060000841, 119060000842, 119090000727, 119100000033, 119150000332, 119240000238, 119240000239, 119240000240, 119250000166, 120010000573, 120290000988, 121400001929, 121430000537, 122050000996, 122090000520, 122090000521, 122090000522, 122090000523, 122090000524, 122090000525, 122090000526, 122090000527, 122090000528, 122170001299, 123250001020, 123340000589, 123520000414, 124060000807, 118480000848, 124060000807, 124170000873, 124170000874, 124170000875, 124170000876, 124170000877, 124170000878, 124170000879, 124170000880, 124170000881, 124170000882, 124280000135, 124280000136, 124280000137, 124280000138, 124280000139, 124320001530; 17) UDI/DI 00732094259612, Serial Numbers: 116120365528; 18) UDI/DI 00732094259650, Serial Numbers: 116240458430, 117220570917, 118120622072, 118170632918, 118180634236, 118300000863, 118330000273, 118330000274, 118420000151, 118440001977, 118480000847, 118520000564, 119170000630, 119270000360, 119270000361, 119270000362, 119350003349, 119380001118, 119380001119, 119430000811, 119340002163, 119470001921, 120050001766, 120050001767, 120050001768, 120130001344, 120140002540, 120180001090, 120180001094, 120220000883, 120320001828, 120330000906, 120380000317, 120450001959, 120450001960, 120450001961, 120450001962, 120460002493, 120460002494, 121070000871, 121130001178, 121150000446, 121190000645, 121200001260, 121200001261, 121230001203, 121230001205, 121280001926, 121290000365, 121290000366, 121370002519, 121370002520, 121370002521, 121370002522, 121370002523, 121370002524, 121380000290, 121380000291, 121380000292, 121380000293, 121380000294, 121380000295, 121380000296, 121380000297, 121380000298, 121380000299, 121380000300, 122020001217, 122020001218, 122020001219, 122020001220, 122020001221, 122020001222, 122070000778, 122070000779, 122070000780, 122070000781, 122080000291, 122120002598, 122120002599, 122120002600, 122140000214, 122220001051, 122250001505, 122470000642, 122470000643, 122470000644, 122470000645, 122470000646, 122470000647, 122470000648, 122470000649, 122470000650, 122470000651, 123060000583, 123060000584, 123060000585, 123060000586, 123060000587, 123060000588, 123060000589, 123060000590, 123060000591, 123130000065, 123150000926, 123210000750, 123250001018, 123250001019, 123320000674, 123430000969, 124010000937, 124060000806, 120180001093, 121010002477, 123060000586, 123250001019, 123320000674, 123430000969, 124010000937, 124060000806, 124150000052, 124150000053, 124150000054, 124150000055, 124150000056, 124150000057, 124150000058, 124150000059, 124150000060, 124150000061, 124180000273, 124220000141, 124220000142; 19) UDI/DI 00732094259681, Serial Numbers: 118520000552, 118520000554, 119470001920, 121060000078, 121370000332, 122100000410, 122130000800, 122220000669, 122220000670; 20) UDI/DI 00732094259735, Serial Numbers: 118180635067, 118180635066, 118180635065; 21) UDI/DI 00732094259766, Serial Numbers: 118190636601, 118190636602, 118190636603, 118190636604, 118190636605, 118480000844, 118480000845; 22) UDI/DI 00732094259810, Serial Numbers: 118180635071, 118180635070, 118180635069, 118180635068, 119090000517, 119090000518, 122440001777, 124100001981, 124100001982; 23) UDI/DI 00732094259889, Serial Numbers: 117390588078; 24) UDI/DI 00732094259919, Serial Numbers: 116460538218, 116460538215, 116460538216, 116460538217; 25) UDI/DI 00732094259971, Serial Numbers: 118130624172, 118130624171, 118130624170, 118130624169; 26) UDI/DI 00732094260120, Serial Numbers: 116500544084, 119250000576, 120180001429; 27) UDI/DI 00732094260137, Serial Numbers: 117380586599, 117380586600; 28) UDI/DI 00732094260151, Serial Numbers: 117160563860, 117160563861, 117160563861; 29) UDI/DI 00732094260199, Serial Numbers: 117510602780, 117510602781; 30) UDI/DI 00732094260229, Serial Numbers: 116490541264, 116490541265, 117120557428, 117110556357, 117110556358, 117120557429, 119090000904, 119160000011, 121420001250, 121420001251, 121420001252, 122020000514, 122040000388, 122040000389, 122160000173, 122270001144, 122270001145, 122270001146, 122310000679, 122330000876, 122340000460, 122480000518, 123170000268; 31) UDI/DI 00732094260267, Serial Numbers: 116470539357, 116470539358, 116470539359, 116470539360, 116470539361, 116470539362, 116470539363, 116470539364, 116470539365, 116470539366, 116470539367, 116470539368, 118140625738, 119020000217, 119020000218, 119020000219, 119130001319, 119130001320, 119130001321, 119460001369, 121320001536, 123240001506, 123240001507, 124200000349; 32) UDI/DI 00732094260304, Serial Numbers: 117140562699, 117140562700; 33) UDI/DI 00732094260342, Serial Numbers: 116510545162; 34) UDI/DI 00732094260380, Serial Numbers: 116070308454, 116480540034, 118300000033, 118300000034, 118300000035, 118300000036, 118300000037, 118300000038, 118300000039, 118300000041, 118300000042, 118300000043, 118300000044, 118300000045, 118300000046, 118300000047, 118300000048, 118300000049, 118300000050, 118300000051, 118300000052, 118300000053, 118300000054, 118300000055, 118340000935, 118340000936, 118340000937, 118340000938, 118340000939, 118340000940, 118340000941, 118340000942, 118340000943, 118460001733, 118460001734, 119240000094, 120190001967, 120190001968, 120190001969, 120220001542, 120220001543, 120220001544, 120220001545, 120220001546, 122070001255, 118300000053, 118300000055, 120220001542; 35) UDI/DI 00732094260434, Serial Numbers: 118300000860, 118460001730, 118460001732, 118480000841, 119130000112, 119130000113, 119130000114, 119200001280, 119200001614, 119380001489, 121150000434, 121150000435, 121360000218, 121450000733, 121520000986, 121520000987, 121520000988, 121520000989, 119380001489; 36) UDI/DI 00732094260519, Serial Numbers: 113030149726, 113030149727, 118120623345, 114160206692, 115170254512, 115170254513, 117270576959, 118230000780, 118240001065, 118240001637, 118300000859, 118330001333, 118440000169, 118480000837, 119060000839, 119090000902, 119170000481, 119170000482, 119170000483, 119170000484, 119170000485, 119200000583, 119200001823, 119230002791, 119250000575, 119380001481, 119380001482, 119490000072, 119490000073, 120220000881, 120220000882, 120290000977, 120290000978, 120520000902, 121230000437, 121250001830, 122050000686, 122050000687, 122070000773, 122070000774, 122070000775, 122070000776, 122070000777, 120440001019, 120440001013, 122350000281, 122440001772, 122440001773, 122500001549, 122500001550, 123100001477, 123160001934, 123160001935, 123230001128, 123100001477, 123160001934, 123160001935, 123200001637, 123230001128, 124160002135, 124160002136, 124170000872, 124180000269, 124220001303, 124220001304; 37) UDI/DI 00732094260533, Serial Numbers: 117390588115, 117390588116, 117390588117, 117390588118, 111130075526; 38) UDI/DI 00732094260557, Serial Numbers: 114150206492, 114450235208, 117390588112, 117390588113, 117390588114, 118480000835, 119350003345, 121280001920, 121280001921, 122070001253, 122070001254, 122130000799, 122260000202, 122260000203, 122260000204, 122260000205, 122260000206, 122260000207, 122260000208, 123070001809, 123090001127, 123110000416, 123200001005, 123450001334, 123450001335, 114150206492, 123090001127, 123110000416, 123450001334, 123450001335, 124110001068, 124110001069, 124160000521; 39) UDI/DI 00732094260601, Serial Numbers: 113480185300; 40) UDI/DI 00732094260670, Serial Numbers: 118100617600, 113100154916, 118130624595, 118330000155, 118330000156, 118480000834, 119180000558, 119250001418, 119260000959, 120080000601, 120460002490, 121130001169, 121130001170, 122070001249, 122070001250, 122070001251, 122070001252, 122290000263, 122290000264, 122290000265, 122340000461, 122340000462; 41) UDI/DI 00732094260731, Serial Numbers: 116120368670; 42) UDI/DI 00732094260816, Serial Numbers: 113240166924, 117080554664, 117080554665, 117220571840, 118280000973, 118480000833; 43) UDI/DI 00732094260847, Serial Numbers: 117520603150; 44) UDI/DI 00732094260885, Serial Numbers: 116340523128, 116350524044. 117370586263; 45) UDI/DI 00732094260892, Serial Numbers: 117380586444; 46) UDI/DI 00732094260960, Serial Numbers: 117470596307, 118050609226; 47) UDI/DI 00732094260991, Serial Numbers: 116500543942, 116500543943, 116500543944, 116500543945, 116500543946; 48) UDI/DI 00732094261004, Serial Numbers: 116390529064; 49) UDI/DI 00732094261028, Serial Numbers: 116460538216, 116460538217, 116110348790, 116070311448, 117370586263, 116070311445, 116070311446, 116070311447, 119380001488; 50) UDI/DI 00732094261042, Serial Numbers: K16C001871, K16C001464, 118140625485, 118140625484, 118130623667, 118120623366, 118120623365, 118120623364, 118120623363, 118120623362, 118120623360, 118120623359, 118120623356, 118120623355, 118120623358, 118120623361, 118120623357, 118110619537, 118110619536, 118140625486, 118140625488, 118140625489, 118140625490, 118140625491, 118140625492, 118140625493, 119050000696, 119350003340, 119470002302, 119490000509, 21119350003340, 21119490000509, 119520000628, 120010000572, 120050001447, 21120010000572, 21120050001447, 121010000496, 118120623358; 51) UDI/DI 00732094261196, Serial Numbers: 118270000496, 118270000497, 118270000498, 118310000442, 118310000443, 118310000444, 118310000445, 118310000446, 118310000447, 118460002316; 52) UDI/DI 00732094294255, Serial Numbers: 118280001663, 118280001664, 118450000678, 118450000679, 118280001663; 53) UDI/DI 00732094294538, Serial Numbers: 120140002538, 120140002539, 120320001826, 120320001827, 121060001018, 122220000671; 54) UDI/DI 00732094294545, Serial Numbers: 122170001364; 55) UDI/DI 00732094295429, Serial Numbers: 118360000421, 118370002214; 56) UDI/DI 00732094296303, Serial Numbers: 119420001730, 119420001731, 119420001732, 119420001733, 119420001734, 119420001735, 119420001736, 121510000646, 121510000647, 121500000303, 123180000483, 123180000484; 57) UDI/DI 00732094299908, Serial Numbers: 11810623357; 58) UDI/DI 00732094299915, Serial Numbers: 118120623355, 118120623356, 118120623365, 118120623359, 118120623363; 59) UDI/DI 00732094301472, Serial Numbers: 117500600621, 120440000589, 120440000590, 120440000591, 120440000592, 120440000593, 122440001762, 21120440000592, 12244001762, 122470000639; 60) UDI/DI 00732094302974, Serial Numbers: 119020000643, 121320001539, 121320001540, 121320001541, 12341, 12342, 12343, 121420001245, 121420001246, 121420001247, 121420001248; 61) UDI/DI 00732094316926, Serial Numbers: 119140001089, 119460000150, 119460000151; 62) UDI/DI 00732094320176, Serial Numbers: 122360001053, ....; 63) UDI/DI 00732094320183, Serial Numbers: 120110001003, 121050001860; 64) UDI/DI 00732094332780, Serial Numbers: 117470596305, 120070001961, 120070001962, 120070001963, 120070001964, 120070001965, 120070001966, 120070001967, 120070001968, 120070001969, 120070001970, 120070001971, 120070001972, 120070001973, 120070001974, 120070001975, 120070001976, 120070001977, 120070001978, 120070001979, 120070001980, 120070001965, 120070001970, 120070001978; 65) UDI/DI 00732094337518, Serial Numbers: 115350269606, 120270000572, 121470000326; 66) UDI/DI 00732094338805, Serial Numbers: 114340225721; 67) UDI/DI 00732094339444, Serial Numbers: 120400001336; 68) UDI/DI 00812345027556, Serial Numbers: 116130382889, 116250489751, 116490541979, 117260576365, 118260000798, 118260000799, 117270577497, 117270577498, 118400001533, 118460001735, 119100000089, 119100000090, 120450001963, 120530000477, 121140001840, 121250000689, 121380000301, 121400001503, 121500001615, 121500001616, 122020001911, 122020001912, 122100000411, 122130000801, 122130000802, 122130000803, 122370001278, 122390000503, 122390000504, 122390000505, 122480002479, 122510000876, 123080000426, 123080000427, 123170000296, 123520001479, 123520001480, 124030000954, 123520001474, 121380000301, 124030000954, 124170000105, 124190001474; 69) UDI/DI 00817655021997, Serial Numbers: 117370585639

Distribution pattern

Worldwide distribution.