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U.S. Department of Health and Human Services

Class 2 Device Recall Axiom Artis Systems operating with A100 Generator

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 Class 2 Recall
Axiom Artis Systems operating with A100 Generator
see related information
Date Posted April 05, 2010
Recall Status1 Terminated on July 05, 2012
Recall Number Z-1237-2010
Recall Event ID 54999
Premarket Notification
510(K) Number
K021021 
Product Classification Solid State X-Ray Imager (Flat Panel/Digital Imager) - Product Code MQB
Product Axiom Artis Systems operating with A100 Generator
Code Information 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.
Recalling Firm/
Manufacturer
Siemens Medical Solutions USA, Inc
51 Valley Stream Pkwy
Malvern, Pennsylvania 19355
Consumer Instructions No consumer action necessary
For Additional Information Contact Technical Solutions
888-826-9702
Manufacturer Reason
for Recall
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
FDA Determined
Cause 2
COMPONENT CONTROLS (GMP - GOOD MANUFACTURING PRACTICE): 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 in Commerce 1373 units
Distribution The product was shipped to medical facilities nationwide.
Total Product Life Cycle TPLC Device Report

 
1 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
510(K) Database 510(K)s with Product Code = MQB and Original Applicant = SIEMENS MEDICAL SOLUTIONS USA, INC.
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