Events

Rappel de Device Recall Axiom Artis Operating Systems with VB22, VB23, VB30, and VB31

Selon U.S. Food and Drug Administration, ce/cet/cette rappel concerne un dispositif en/au/aux/à United States qui a été fabriqué par Siemens Medical Solutions USA, Inc.

Qu'est-ce que c'est?

Une correction ou un retrait opéré par un fabricant afin de répondre à un problème causé par un dispositif médical. Les rappels surviennent lorsqu'un dispositif médical est défectueux, lorsqu'il pourrait poser un risque pour la santé, ou les deux à la fois.

En savoir plus sur les données ici
  • Type d'événement
    Recall
  • ID de l'événement
    54846
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-1312-2010
  • Date de mise en oeuvre de l'événement
    2010-02-16
  • Date de publication de l'événement
    2010-04-08
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2012-07-05
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=89310
  • Notes / Alertes
    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.
  • Notes supplémentaires dans les données
    Angiographic X-Ray System - Product Code IZI
  • Cause
    Communication problems can occur which may result in unavailability of bypass fluoro.
  • Action
    The recalling firm issued a Customer Safety Advisory Notice dated 2/16/10 to inform their customers of the problem. The letter identified the affected product and stated that the problem had been solved by the service technician by the time that customers would receive the letter. The letter also explained when the problem occurred and the possible risks associated with it. In addition, the firm stated what will be done to avoid the problem.

Device

Device Recall Axiom Artis Operating Systems with VB22, VB23, VB30, and VB31
  • Modèle / numéro de série
    Model number 5917054 - Serial numbers: 49004, 49006, and 49008; Model number 7008605 - Serial numbers: 55164, 55167, 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, 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, 55513, 55518, 55526, 55531, 55545, 55548, 55550, 55553, 55567, 55569, 55574, 55575, 55576, 55708, 55713, and 55715; Model number 7412807 - Serial numbers: 35427, 35431, 35432, 35438, 35439, 35441, 35442, 35451, 35452, 35456, 35465, 35466, 35467, 35469, 35471, 35472, 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, 35828, 35831, 35834, 35836, 35893, 35908, 35909, 35916, 35918, 35921, 35937, 35945, 35968, 35971, 37705, 37706, 37708, 37709, 37710, 37711, 37713, 37715, and 37716; Model number 7413078 - Serial numbers: 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, 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, 46239, 46241, 46245, 46251, 46256, 46262, 46263, 46269, 46270, 46271, and 46272; Model number 7555357 - Serial numbers: 53058, 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, 53706, and 53710; Model number 7555365 - Serial numbers: 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: 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, 51706, and 51707; and Model number 7728392 - Serial numbers: 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.
  • Classification du dispositif
    Radiology Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Nationwide Distribution
  • Description du dispositif
    Axiom Artis Systems Operating with VB22, VB23, VB30, and VB31. Model number 5917054, 7008605, 7412807, 7413078, 7555357, 7555365, 7555373, and 7728392. || Intended use: Angiographic x-ray system.
  • Manufacturer
    Siemens Medical Solutions USA, Inc

Manufacturer

Siemens Medical Solutions USA, Inc
  • Adresse du fabricant
    Siemens Medical Solutions USA, Inc, 51 Valley Stream Pkwy, Malvern PA 19355
  • Société-mère du fabricant (2017)
    Siemens Ag
  • Source
    USFDA