FDA Home Page | CDRH Home Page | Search | A-Z Index

510(k) | Registration & Listing | Adverse Events | PMA | Classification | CLIA CFR Title 21 | Advisory Committees | Assembler | Recalls | Guidance | Standards

New Search Back To Search Results   Medical Device Recalls Class 2 Recall Axiom Artis Date Recall Initiated August 22, 2008 Date Posted November 04, 2008 Recall Number Z-0193-2009 Product AXIOM Artis. Angiographic X-ray System. Code Information 5097, 35098, 35099, 35108, 35112, 35113, 35114, 35121, 35122, 35125, 35126, 35129, 35131, 35133, 35135, 35136, 35142, 35143, 35149, 35156, 35157, 35158, 35159, 35160, 35161, 35162, 35168, 35174, 35179, 35183, 35184, 35186, 35190, 35192, 35193, 35194, 35201, 35202, 35213, 35215, 35217, 35228, 35232, 35238, 35240, 35241, 35244, 35249, 35253, 35258, 35261, 35191, 35208, 35239, 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, 35413, 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, 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, 35831, 35828, 35834, 35836, 35893, 37700, 37701, 37702, 37705, 37706, 37708, 37709, 37710, 37711, 37713, 37715, 37716, 40000, 40001, 40006, 40007, 40009, 40010, 40011, 40012, 40013, 40014, 40015, 40016, 40017, 40018, 40019, 40020, 40023, 40025, 40027, 40029, 40030, 40031, 40032, 40034, 40035, 40038, 40039, 40048, 40049, 40050, 40053, 40059, 40061, 40062, 40064, 40065, 40066, 40067, 40070, 40071, 44005, 44011, 44016, 44021, 44030, 44032, 44034, 44041, 44043, 44046, 44048, 44056, 44060, 44068, 44072, 44075, 44076, 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, 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, 46004, 46005, 46012, 46013, 46014, 46017, 46018, 46022, 46023, 46025, 46026, 46027, 46032, 46033, 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, 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, 46241, 46245, 46251, 46256, 49001, 49002, 49004, 49006, 49008, 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, 51700, 51706, 51707, 53002, 53003, 53005, 53009, 53011, 53012, 53016, 53017, 53019, 53020, 53022, 53023, 53026, 53028, 53031, 53032, 53033, 53035, 53037, 53043, 53045, 53047, 53049, 53056, 53057, 53058, 53063, 53064, 53065, 53066, 53067, 53070, 53073, 53075, 53076, 53078, 53082, 53083, 53084, 53085, 53086, 53090, 53093, 53094, 53098, 53102, 53103, 53104, 53109, 53111, 53113, 53114, 53115, 53116, 53117, 53122, 53124, 53125, 53128, 53131, 53133, 53135, 53139, 53140, 53141, 53142, 53147, 53149, 53152, 53159, 53160, 53161, 53162, 53165, 53166, 53167, 53170, 53174, 53175, 53176, 53178, 53180, 53181, 53182, 53185, 53187, 53188, 53189, 53190, 53191, 53194, 53195, 53196, 53201, 53202, 53209, 53215, 53219, 53222, 53223, 53225, 53227, 53700, 53702, 53703, 53706, 53710, 55002, 55003, 55008, 55010, 55012, 55013, 55015, 55017, 55019, 55021, 55023, 55025, 55028, 55030, 55031, 55037, 55039, 55040, 55041, 55042, 55043, 55045, 55046, 55048, 55051, 55052, 55053, 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, 52242, 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, 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, 55702, 55704, 55705, 55707, 55708, 55713, 55715, 57004, 57008, 57009, 57012, 57016, 57024, 57035, 57041, 57045, 57054, 57072, 57073, 57076, 57077, 57089, 57098, 57101, 57105, 57111, 57113, 57117, 57124, 57144, 57155, 57156, 57171, 57183, and 57187.Serial numbers: 10012, 10013, 10014, 10017, 10020, 10026, 10028, 10029, 10031, 10036, 10041, 10042, 10046, 10047, 10051, 10052, 10053, 10060, 10063, 10064, 10067, 10070, 10072, 10073, 10075, 10078, 10081, 10082, 10083, 10084, 10089, 10092, 10093, 10094, 10096, 10099, 10101, 10116, 10121, 10122, 10123, 10124, 10129, 10131, 10134, 10135, 10136, 10138, 10141, 10142, 10143, 10149, 10150, 10156, 10157, 10158, 10159, 10161, 10167, 10171, 10173, 10175, 10176, 10179, 10180, 10182, 10188, 10192, 10195, 10196, 10197, 10198, 10210, 10217, 10218, 10223, 10226, 10229, 10231, 10232, 10233, 10234, 10235, 10238, 10240, 10241, 10242, 10245, 10246, 10248, 10251, 10252, 10254, 10255, 10257, 10258, 10259, 10261, 10263, 10265, 10266, 10275, 10280, 10284, 10292, 10293, 10295, 10296, 10298, 10299, 10300, 10302, 10303, 10304, 10305, 10307, 10308, 10309, 10310, 10314, 10321, 10326, 10327, 10328, 10329, 10331, 10332, 10333, 10336, 10337, 10338, 10340, 10343, 10345, 10346, 10350, 10355, 10356, 10357, 10364, 10366, 10367, 10368, 10369, 10371, 10373, 10374, 10381, 10388, 10389, 10390, 10391, 10392, 10407, 10412, 10415, 10424, 10425, 10427, 10428, 14029, 10430, 10431, 10432, 10433, 10434, 10435, 10438, 10477, 10482, 10488, 14004, 14010, 14016, 14017, 14019, 14027, 14030, 14036, 14037, 14039, 14040, 14043, 10444, 14047, 14048, 14049, 14055, 14057, 14064, 14068, 14070, 14072, 14073, 14076, 14078, 14082, 14083, 14088, 14090, 14091, 14093, 14094, 14095, 14096, 14098, 14099, 14101, 14104, 14106, 14108, 14109, 14110, 14111, 14112, 20003, 20015, 20016, 20033, 20037, 20050, 20053, 20056, 20074, 20076, 20081, 20086, 20087, 20097, 20100, 20102, 20114, 20129, 20136, 20140, 20141, 20143, 20157, 20165, 20170, 20171, 20172, 20175, 20178, 20179, 20180, 20181, 20182, 20183, 20185, 20188, 20202, 20205, 20207, 20208, 20209, 20217, 20220, 20230, 20233, 20238, 20242, 20243, 20249, 20250, 20254, 20258, 20264, 20265, 20281, 20282, 20294, 20295, 20303, 20313, 20321, 20322, 20325, 20334, 20338, 20339, 20343, 20348, 25004, 25013, 25015, 25024, 25037, 25040, 25041, 25044, 25045, 25046, 25052, 25054, 25056, 25061, 25063, 25068, 25069, 25071, 25073, 25075, 25077, 25079, 25082, 25084, 25085, 25087, 25088, 25089, 25090, 25092, 25094, 25101, 25107, 25108, 25111, 25112, 25115, 25122, 25123, 25125, 25127, 25134, 25135, 25136, 25141, 25142, 25143, 25145, 25148, 25156, 25157, 25159, 25160, 25163, 25169, 25170, 25173, 25176, 25178, 25181, 25182, 25183, 25186, 25189, 25190, 25194, 25195, 25197, 25202, 25204, 25209, 25213, 25215, 25220, 25230, 25233, 25234, 25237, 25240, 25241, 25242, 25252, 25259, 25260, 25262, 25267, 25273, 25275, 25279, 25280, 25283, 25286, 25290, 25293, 25295, 25296, 25299, 25303, 25308, 25328, 25335, 25349, 25355, 25376, 25382, 25403, 28006, 28010, 28012, 28014, 28015, 28017, 28018, 28019, 28020, 28021, 28023, 28025, 28027, 28028, 28031, 28033, 28035, 28036, 28040, 28041, 28042, 28043, 28044, 28045, 28046, 28047, 28049, 28051, 28053, 28058, 28059, 28061, 28062, 28065, 28066, 28067, 28070, 28073, 28075, 28079, 28081, 28088, 28089, 28090, 28093, 28096, 28099, 28100, 28105, 28107, 28108, 28109, 28111, 28112, 28114, 28116, 28117, 28118, 28119, 28120, 28121, 28123, 28126, 28131, 28136, 28137, 28138, 28139, 28142, 28144, 28145, 28150, 28151, 28153, 28154, 28155, 28156, 28157, 28158, 28159, 28160, 28161, 28163, 30002, 30003, 30004, 30005, 30006, 30007, 32004, 32007, 32008, 32010, 32011, 32017, 32018, 32019, 32022, 32023, 32025, 32026, 32027, 32029, 32031, 32032, 32033, 32034, 32035, 32039, 32040, 32042, 32045, 32047, 32048, 32049, 32050, 32051, 32052, 32055, 32056, 32057, 32059, 32066, 32074, 32075, 32077, 32079, 32080, 32085, 32090, 32091, 32092, 32093, 32094, 32095, 32097, 32099, 32101, 32102, 32103, 32106, 35004, 35007, 35008, 35014, 35015, 35018, 35019, 35020, 35026, 35034, 35036, 35042, 35044, 35045, 35046, 35048, 35050, 35053, 35054, 35055, 35056, 35057, 35059, 35061, 35064, 35066, 35067, 35069, 35070, 35071, 35073, 35075, 35076, 35079, 35080, 35083, 35088, 35090, 35095, 3 Recalling Firm/ Manufacturer Siemens Medical Solutions USA, Inc 51 Valley Stream Pkwy Malvern , Pennsylvania 19355-1406 For Addition Information Contact Michael Van Ryn 610-448-4634 Reason For Recall Patients could possibly fall off the table if not properly secured when: 1) moving them onto the patient table, 2) moving them on the patient table or 3) removing them from the patient table. Action The recalling firm issued a Customer Safety Advisory Notice dated 7/04/08 (including an Addendum to the Operators Manual) which alerts the operator of possible injury to patients if they are not properly secured to the table during examinations and describes the recommended fastening procedures required to properly secure the patient to the table. For questions or additional information, contact Siemens Medical Solutions, Inc. at 610-448-4634. Quantity in Commerce 1,530 units Distribution Nationwide Distribution.

CDRH Home Page | CDRH A-Z Index | Contact CDRH | Accessibility | Disclaimer
FDA Home Page | Search FDA Site | FDA A-Z Index | Contact FDA | HHS Home Page

Center for Devices and Radiological Health / CDRH