FDAFDA · Alimentos y medicamentos·N.º oficial Z-0323-2025
Hillrom Welch Allyn Vision Express Holter Analysis System; Electrocardiograph
Publicado el 13 de noviembre de 2024 · Inicio del retiro: 11 de octubre de 2024
Estado reportado al momento de publicación: Ongoing — openFDA actualiza semanalmente y este campo no refleja el estado más reciente. Confirma siempre con la fuente oficial.
Qué peligro representa
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.
Qué hacer
Voluntary: Firm initiated · Letter
Detalles del retiro
- Fabricante
- Baxter Healthcare Corporation
- Distribuidor
- Worldwide distribution.
- Lote
- 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
- Clasificación de riesgo
- Class II
- Área (FDA)
- device
- País
- United States
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