Events

Retiro De Equipo (Recall) de Device Recall Axiom Artis

Según U.S. Food and Drug Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en United States que fue producido por Siemens Medical Solutions USA, Inc.

¿Qué es esto?

Una corrección al equipo o acción de retiro tomada por el fabricante para abordar un problema con un dispositivo médico. Los retiros (recalls) ocurren cuando un dispositivo médico está defectuoso, cuando puede poner en riesgo la salud, o cuando simultáneamente está defectuoso y puede poner en riesgo la salud.

Más información acerca de la data acá
  • Tipo de evento
    Recall
  • ID del evento
    49529
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-0193-2009
  • Fecha de inicio del evento
    2008-08-22
  • Fecha de publicación del evento
    2008-11-04
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2009-09-23
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=73743
  • Notas / Alertas
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Notas adicionales en la data
    Angiographic X-ray System - Product Code IZI
  • Causa
    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.
  • Acción
    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.

Device

Device Recall Axiom Artis
  • Modelo / Serial
    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, 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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, 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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, 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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.
  • Clasificación del producto
    Radiology Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Nationwide Distribution.
  • Descripción del producto
    AXIOM Artis. Angiographic X-ray System.
  • Manufacturer
    Siemens Medical Solutions USA, Inc

Manufacturer

Siemens Medical Solutions USA, Inc
  • Dirección del fabricante
    Siemens Medical Solutions USA, Inc, 51 Valley Stream Pkwy, Malvern PA 19355
  • Empresa matriz del fabricante (2017)
    Siemens Ag
  • Source
    USFDA