Baxter Healthcare Corporation Recall 95559
Description: Hillrom Welch Allyn Vision Express Holter Analysis System; Electrocardiograph
Baxter Healthcare Corporation Recall 95559 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | Z-0323-2025 |
| Event ID | 95559 |
| Event Description | Hillrom Welch Allyn Vision Express Holter Analysis System; Electrocardiograph |
| Product Type | Devices |
| Distribution | Worldwide distribution. |
| Quantity | 1003 units |
| Recall Reason | 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 patient s identification with their physiological data. |
| Device Classification | 20241113 |
| Device Code Info | 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 |
| Center Classification Date | 20241107 |
| Recall Initiation Date | 20241011 |
| Recalling Firm | Baxter Healthcare Corporation |
| Initial Notification | Letter |
| Similar To |