Device Recall Axiom Artis Operating Systems with VB22, VB23, VB30, and VB31

  • 모델명 / 제조번호(시리얼번호)
    Model number 5917054 - Serial numbers: 49004, 49006, and 49008; Model number 7008605 - Serial numbers: 55164, 55167, 55171, 55175, 55177, 55181, 55183, 55184, 55186, 55187, 55188, 55191, 55196, 55199, 55200, 55202, 55204, 55206, 55210, 55211, 55212, 55213, 55215, 55216, 55217, 55218, 55219, 55220, 55222, 55223, 55224, 55227, 55228, 55230, 55231, 55232, 55233, 55234, 55238, 55241, 55242, 55243, 55244, 55246, 55249, 55254, 55256, 55258, 55259, 55260, 55261, 55262, 55263, 55269, 55270, 55272, 55273, 55274, 55275, 55276, 55277, 55279, 55282, 55284, 55285, 55286, 55287, 55288, 55289, 55292, 55294, 55298, 55299, 55304, 55305, 55306, 55307, 55308, 55310, 55312, 55313, 55314, 55316, 55318, 55320, 55322, 55324, 55325, 55326, 55329, 55335, 55337, 55338, 55342, 55343, 55347, 55349, 55350, 55353, 55354, 55355, 55356, 55358, 55359, 55362, 55365, 55368, 55369, 55374, 55375, 55376, 55377, 55378, 55381, 55382, 55384, 55385, 55386, 55387, 55388, 55392, 55394, 55395, 55396, 55399, 55400, 55401, 55404, 55405, 55407, 55408, 55409, 55410, 55411, 55412, 55414, 55415, 55416, 55423, 55425, 55426, 55434, 55435, 55436, 55438, 55439, 55441, 55443, 55455, 55461, 55462, 55466, 55468, 55469, 55470, 55473, 55477, 55483, 55503, 55513, 55518, 55526, 55531, 55545, 55548, 55550, 55553, 55567, 55569, 55574, 55575, 55576, 55708, 55713, and 55715; Model number 7412807 - Serial numbers: 35427, 35431, 35432, 35438, 35439, 35441, 35442, 35451, 35452, 35456, 35465, 35466, 35467, 35469, 35471, 35472, 35486, 35490, 35499, 35501, 35502, 35504, 35508, 35511, 35512, 35516, 35518, 35522, 35525, 35528, 35529, 35535, 35536, 35538, 35540, 35545, 35547, 35550, 35553, 35556, 35560, 35561, 35562, 35566, 35567, 35571, 35577, 35580, 35581, 35599, 35600, 35601, 35603, 35604, 35610, 35613, 35614, 35615, 35623, 35626, 35627, 35629, 35634, 35635, 35649, 35651, 35652, 35655, 35659, 35660, 35663, 35664, 35665, 35666, 35668, 35669, 35670, 35672, 35678, 35683, 35684, 35690, 35695, 35698, 35704, 35707, 35709, 35710, 35712, 35714, 35727, 35728, 35730, 35732, 35734, 35736, 35739, 35741, 35743, 35744, 35745, 35750, 35762, 35764, 35768, 35776, 35778, 35782, 35783, 35784, 35787, 35788, 35789, 35793, 35802, 35810, 35815, 35821, 35828, 35831, 35834, 35836, 35893, 35908, 35909, 35916, 35918, 35921, 35937, 35945, 35968, 35971, 37705, 37706, 37708, 37709, 37710, 37711, 37713, 37715, and 37716; Model number 7413078 - Serial numbers: 46077, 46079, 46080, 46082, 46085, 46086, 46087, 46091, 46097, 46098, 46099, 46100, 46101, 46103, 46105, 46106, 46107, 46108, 46111, 46112, 46113, 46114, 46115, 46117, 46118, 46120, 46121, 46122, 46124, 46125, 46126, 46127, 46128, 46129, 46130, 46133, 46134, 46137, 46138, 46139, 46140, 46141, 46142, 46143, 46144, 46145, 46146, 46147, 46150, 46152, 46153, 46154, 46156, 46157, 46158, 46160, 46162, 46163, 46164, 46166, 46167, 46168, 46169, 46170, 46171, 46172, 46174, 46176, 46178, 46179, 46180, 46182, 46186, 46189, 46190, 46192, 46193, 46194, 46196, 46198, 46201, 46202, 46203, 46204, 46205, 46208, 46209, 46210, 46213, 46215, 46216, 46218, 46219, 46220, 46221, 46223, 46224, 46225, 46226, 46229, 46231, 46232, 46233, 46235, 46236, 46239, 46241, 46245, 46251, 46256, 46262, 46263, 46269, 46270, 46271, and 46272; Model number 7555357 - Serial numbers: 53058, 53065, 53066, 53067, 53070, 53074, 53075, 53076, 53078, 53082, 53083, 53084, 53085, 53086, 53090, 53093, 53094, 53096, 53098, 53102, 53103, 53104, 53109, 53111, 53113, 53114, 53115, 53116, 53117, 53122, 53124, 53125, 53128, 53131, 53133, 53135, 53140, 53141, 53142, 53146, 53147, 53149, 53152, 53159, 53160, 53161, 53162, 53165, 53166, 53167, 53170, 53175, 53176, 53178, 53180, 53181, 53182, 53185, 53187, 53188, 53189, 53190, 53191, 53194, 53195, 53196, 53201, 53202, 53209, 53215, 53219, 53222, 53223, 53225, 53227, 53253, 53256, 53260, 53261, 53263, 53264, 53706, and 53710; Model number 7555365 - Serial numbers: 57041, 57045, 57054, 57072, 57073, 57076, 57077, 57089, 57098, 57105, 57111, 57113, 57116, 57117, 57124, 57144, 57155.57156, 57171, 57183, 57187, 57188, 57189, 57193, 57198, 57201, and 57204; Model number 7555373 - Serial numbers: 50046, 50048, 50050, 50057, 50059, 50062, 50063, 50064, 50065, 50074, 50079, 50081, 50084, 50087, 50093, 50096, 50101, 50105, 50120, 50132, 50133, 50139, 50142, 50161, 50167, 50176, 50187, 50189, 50191, 51706, and 51707; and Model number 7728392 - Serial numbers: 44118, 44122, 44125, 44134, 44135, 44136, 44144, 44145, 44151, 44152, 44155, 44157, 44163, 44165, 44168, 44169, 44171, 44174, 44184, 44185, 44189, 44190, 44193, 44195, 44198, 44199, 44201, 44206, 44210, 44211, 44215, 44218, 44223, 44224, 44227, 44229, 44242, 44243, 44244, 44246, 44251, 44254, 44255, 44259, 44260, 44262, 44263, 44264, 44265, 44267, 44268, 44271, 44275, 44277, 44278, 44279, 44280, 44282, 44286, 44289, 44290, 44292, 44304, and 44316.
  • 의료기기 분류등급
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Nationwide Distribution
  • 제품 설명
    Axiom Artis Systems Operating with VB22, VB23, VB30, and VB31. Model number 5917054, 7008605, 7412807, 7413078, 7555357, 7555365, 7555373, and 7728392. || Intended use: Angiographic x-ray system.
  • Manufacturer
  • 1 Event

제조사

  • 제조사 주소
    Siemens Medical Solutions USA, Inc, 51 Valley Stream Pkwy, Malvern PA 19355
  • 제조사 모회사 (2017)
  • Source
    USFDA