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Vision Express recallZ-0323-2025 · Baxter Healthcare Corporation · initiated Oct 11, 2024

Open, Classified

Is my device affected?

  1. Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
  2. If yours is listed, follow the instructions from Baxter Healthcare Corporation or your healthcare provider. The company's action is summarized under what the company is doing.
  3. Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

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.

FDA root cause category: Software design

What the company is doing

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.

Recall details

Recall number
Z-0323-2025
Status
Open, Classified
Initiated by the company
Oct 11, 2024
Posted by the FDA
Nov 7, 2024
Recalling firm
Baxter Healthcare Corporation
Quantity
1003 units
Product code
MLO
FDA submissions
K004017
Distribution
Worldwide distribution.

Product description

Hillrom Welch Allyn Vision Express Holter Analysis System; Electrocardiograph

Code information (models, lots, serial numbers)

Show the full code information (14k characters)

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

Devices named in this recall

5 devices in the FDA device registry whose identifier appears in the recall's code information.

Product lines

Other devices under the same FDA submission

5 devices cleared under K004017 are not named by identifier in this recall. One submission often covers many models, so they may or may not be affected.

Other products in the same recall event

The FDA groups related products into one recall event (event 95559).

Sources and updates

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