Siemens Medical Solutions USA, Inc: Axiom Artis Systems operating with A100 Generator

Recall number

Z-1237-2010

Recalling firm

Siemens Medical Solutions USA, Inc

Product

Axiom Artis Systems operating with A100 Generator

Status

Terminated

Initiated

2010-03-04

Posted

2010-04-05

Terminated

2012-07-05

Reason

Due to a contact problem at the low voltage power supply of the generator controller, in rare cases where a user has invoked radiation, it may occur that no radiation is released. Under certain circumstances, radiation is possible by repeated release of the x-ray footswitch or button. To remedy the issue described above, a revised cabling has been installed in all potentially affected syste

Root cause

Nonconforming Material/Component

Action

The recalling firm issued a Customer Safety Advisory to affected customers via Update Instructions AX006/10/S. The letter informs customers of the potential issues and provides additional information on the implemented resolutions. For additional information, please contact the firm at 888-826-9702.

Quantity

1373 units

Distribution

The product was shipped to medical facilities nationwide.

Lot, serial or model codes

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.

510(k) numbers

["K021021"]

PMA numbers

not on file

Product code

MQB

Firm FEI

2240869

Firm city

Malvern

Firm state

PA

Firm country

not on file

Cite as

FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28

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