FDAFDA · Food and drugs·Recall number Z-0323-2025
Hillrom Welch Allyn Vision Express Holter Analysis System; Electrocardiograph
Published November 13, 2024 · Recall initiated: October 11, 2024
Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
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.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Baxter Healthcare Corporation
- Distributor
- Worldwide distribution.
- Lot
- 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, 1194400004
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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