Devices

Device Recall Axiom Artis Systems operating with A100 Generator

Model / Serial
Model number 10094135 - Serial numbers: 135000, 135102, 135109, 135111, 135112, 135114, 135117, 135120, 135122, 135124, 135125, 135128, 135129, 135132, 135133, 135137, 135143, 135144, 135145, 135148, 135151, 135152, 135157, 135169, 135179, 135180, 135182, 135184, 135190, 135196, 135199, 135200, 135201, 135203, 135204, 135209, 135217, 135222, 135229, 135233, 135235, 135245, 135253, 135258, 135260, 135264, 135279, 135281, 135285, 135286, 135302, 135309, 135322, 135353, 135358, 135366, 135373, 135375, 135384, 135388, 135394, 135397, 135404, 135406, 135413, 135416, 135420, 135421, and 135424; Model number 10094137 - Serial numbers: 146103, 146104, 146107, 146111, 146113, 146116, 146118, 146119, 146121, 146122, 146123, 146130, 146136, 146137, 146138, 146139, 146140, 146144, 146147, 146149, 146150, 146152, 146154, 146155, 146156, 146158, 146159, 146161, 146164, 146166, 146167, 146168, 146169, 146170, 146171, 146173, 146174, 146175, 146176, 146178, 146179, 146181, 146182, 146183, 146184, 146186, 146187, 146188, 146189, 146192, 146193, 146195, 146197, 146201, 146205, 146206, 146210, 146211, 146212, 146217, 146218, 146219, 146220, 146221, 146223, 146232, 146233, 146234, 146235, 146238, 146239, 146241, 146242, 146245, 146246, 146248, 146249, 146251, 146254, 146256, 146257, 146260, 146263, 146264, 146266, 146267, 146272, 146274, 146277, 146279, 146285, 146286, 146287, 146289, 146290, 146292, 146293, 146297, 146298, 146299, 146302, 146305, 146308, 146313, 146320, 146322, 146323, 146324, 146326, 146327, 146333, 146334, 146335, 146337, 146338, 146339, 146340, 146341, 146342, 146343, 146345, 146348, 146352, 146353, 146354, 146355, 146357, 146361, 146365, 146366, 146368, 146369, 146370, 146372, 146373, 146382, 146386, 146388, and 146391; Model number 10094139 - Serial numbers: 157136, 157139, 157146, 157156, 157164, 157165, 157168, 157169, 157184, and 157213; Model number 10094141 - Serial numbers: 153101, 153102, 153106, 153107, 153109, 153110, 153111, 153112, 153113, 153115, 153117, 153119, 153120, 153122, 153124, 153125, 153128, 153129, 153130, 153131, 153134, 153135, 153138, 153139, 153141, 153145, 153147, 153148, 153150, 153153, 153154, 153155, 153156, 153157, 153159, 153160, 153161, 153164, 153166, 153167, 153169, 153171, 153172, 153173, 153176, 153178, 153180, 153186, 153190, 153191, 153194, 153195, 153197, 153199, 153201, 153206, 153211, 153214, 153215, 153216, 153217, 153220, 153225, 153226, 153227, 153229, 153232, 153234, 153235, 153236, 153239, 153245, 153248, 153249, 153250, 153251, 153252, 153254, 153255, 153256, 153257, 153259, 153263, 153264, 153265, 153268, 153269, 153270, 153271, 153273, 153274, 153276, 153277, 153280, 153283, 153285, 153289, 153290, 153299, 153304, 153311, 153314, 153315, 153317, 153318, 153323, 153325, 153327, 153328, 153329, 153332, 153335, 153338, 153341, 153342, 153343, 153344, 153345, 153347, 153348, and 153351; Model number 10094142 - Serial numbers: 140100, 140101, 140102, 140105, 140106, 140108, 140109, and 140114; Model number 10094143 - Serial numbers 149100 and 149101; Model number 10280959 - Serial numbers: 160006, 160008, 160100, 160101, 160106, 160114, 160115, 160116, 160119, 160122, 160128, 160129, 160131, 160134, 160136, 160137, 160138, 160141, 160142, 160144, and 160147; Model number 5904433 - Serial numbers: 10407, 10412, 10415, 10424, 10425, 10427, 10428, 10430, 10431, 10432, 10433, 10435, 10436, 10438, 10444, 10477, and 10482; Model number 5904441 - Serial numbers: 25303, 25308, 25328, 25335, 25349, 25355, 25376, 25382, and 25403; Model number 5904466 - Serial numbers: 20052, 20238, 20242, 20243, 20249, 20250, 20254, 20258, 20264, 20265, 20281, 20282, 20294, 20295, 20303, 20313, 20321, 20322, 20325, 20334, 20338, 20339, 20343, 20348, and 20363; Model number 5904649 - Serial numbers: 14094, 14099, 14101, 14106, 14108, 14109, 14110, 14111, and 14112; Model number 5904656 - Serial numbers: 28126, 28138, 28139, 28142, 28144, 28145, 28150, 28151, 28153, 28154, 28155, 28156, 28157, 28158, 28159, 28160, 28161, and 28163; Model number 5917054 - Serial numbers: 49001, 49002, 49004, 49006, and 49008; Model number 7007755 - Serial numbers: 32085, 32085, 32090, 32091, 32092, 32093, 32094, 32095, 32097, 32099, 32101, 32102, and 32103; Model number 7008605 - Serial numbers: 55013, 55015, 55017, 55019, 55037, 55039, 55040, 55041, 55042, 55043, 55045, 55046, 55048, 55051, 55052, 55055, 55056, 55057, 55059, 55062, 55067, 55070, 55074, 55078, 55079, 55083, 55085, 55088, 55089, 55090, 55091, 55096, 55100, 55102, 55103, 55106, 55107, 55109, 55118, 55120, 55124, 55125, 55128, 55129, 55131, 55133, 55135, 55136, 55139, 55141, 55149, 55150, 55152, 55153, 55154, 55156, 55157, 55160, 55161, 55162, 55163, 55164, 55167, 55170, 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, 55250, 55254, 55256, 55258, 55259, 55260, 55261, 55262, 55263, 55269, 55270, 55272, 55273, 55274, 55275, 55276, 55277, 55279, 55282, 55284, 55285, 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, 55702, 55704, 55705, 55707, 55708, 55713, and 55715; Model number 7412807 - Serial numbers: 35179, 35217, 35228, 35232, 35238, 35239, 35240, 35241, 35244, 35249, 35253, 35258, 35261, 35262, 35266, 35269, 35279, 35281, 35282, 35283, 35289, 35291, 35296, 35297, 35299, 35301, 35302, 35305, 35306, 35307, 35309, 35312, 35313, 35314, 35320, 35325, 35326, 35327, 35329, 35333, 35334, 35335, 35338, 35339, 35345, 35346, 35349, 35350, 35351, 35352, 35353, 35359, 35361, 35368, 35369, 35371, 35373, 35374, 35376, 35378, 35380, 35390, 35402, 35406, 35407, 35408, 35410, 35411, 35412, 35423, 35427, 35431, 35432, 35438, 35439, 35441, 35442, 35451, 35452, 35456, 35465, 35466, 35467, 35469, 35471, 35472, 35476, 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, 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, 37700, 37701, 37702, 37705, 37706, 37708, 37709, 37710, 37711, 37713, 37715, and 37716; Model number 7413078 - Serial numbers: 46013, 46022, 46023, 46025, 46026, 46027, 46032, 46033, 46034, 46034, 46035, 46036, 46038, 46040, 46042, 46043, 46044, 46045, 46046, 46047, 46048, 46051, 46054, 46055, 46056, 46057, 46060, 46061, 46062, 46063, 46065, 46067, 46068, 46069, 46070, 46071, 46072, 46074, 46075, 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, 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, and 46271; Model number 7555357 - Serial numbers: 53002, 53003, 53009, 53011, 53012, 53016, 53017, 53019, 53020, 53022, 53023, 53026, 53028, 53031, 53033, 53035, 53037, 53043, 53045, 53047, 53049, 53056, 53057, 53058, 53063, 53064, 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, 53700, 53702, 53706, and 53710; Model number 7555365 - Serial numbers: 57004, 57008, 57009, 57012, 57016, 57024, 57035, 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: 50004, 50006, 50009, 50010, 50016, 50017, 50024, 50027, 50033, 50035, 50039, 50040, 50044, 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, 51357, 51700, 51701, 51706, and 51707; Model number 7727717 - Serial numbers: 40017, 40023, 40025, 40027, 40029, 40030, 40031, 40032, 40034, 40035, 40038, 40039, 40048, 40049, 40050, 40053, 40059, 40061, 40062, 40064, 40065, 40066, 40067, 40070, 40071, 40072, 40073, and 40075; Model number 7728350 - Serial numbers 30006 and 30007; and Model number 7728392 - Serial numbers: 44056, 44060, 44068, 44072, 44075, 44077, 44080, 44081, 44084, 44085, 44087, 44090, 44094, 44100, 44101, 44104, 44105, 44108, 44117, 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.
Product Classification
Radiology Devices
Device Class
2
Implanted device?
No
Distribution
The product was shipped to medical facilities nationwide.
Product Description
Axiom Artis Systems operating with A100 Generator
Manufacturer
Siemens Medical Solutions USA, Inc
1 Event
- Recall of Device Recall Axiom Artis Systems operating with A100 Generator

Manufacturer

Siemens Medical Solutions USA, Inc

Manufacturer Address
Siemens Medical Solutions USA, Inc, 51 Valley Stream Pkwy, Malvern PA 19355
Manufacturer Parent Company (2017)
Siemens Ag
Source
USFDA

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