Events

Rappel de Device Recall AXIOM Artis MP/Artis dMP and Artis zee Multipurpose

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
    56262
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-2233-2010
  • Date de mise en oeuvre de l'événement
    2010-07-13
  • Date de publication de l'événement
    2010-08-16
  • 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=93086
  • 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
    System, x-ray, angiographic - Product Code IZI
  • Cause
    The axiom artis mp, artis dmp or artis zee multipurpose c-arm gearbox can become damaged. if the gearbox is damaged, the c-arm may tilt away when being repositioned and collide with nearby objects in its range of motion.
  • Action
    Siemens has issued an "Urgent Field Safety Notice: Customer Safety Information to consignees with Update Instructions AX033/10/S. This letter informed customers of the issue, and provides an Addendum to the User Manual. The Update Instructions describe the process for installation of an additional clamping mechanism provided by Siemens into the existing system, which will be activated if the gearbox is damaged. If activated, the clamping machanism will prevent the C-arm from tilting away, stop regular operation, and alert the operator to check the system and repair the gearbox damage.

Device

Device Recall AXIOM Artis MP/Artis dMP and Artis zee Multipurpose
  • Modèle / numéro de série
    Model numbers 10094139, 5904466, 7555365. Serial numbers 20136, 157435, 20205, 57089, 20334, 20114, 57077, 157458, 20052, 20303, 20343, 20016, 157136, 20208, 20238, 20242, 157436, 57144, 57189, 20322, 20295, 20081, 157448, 20209, 157165, 20254, 20170, 20282, 20076, 157168, 20050, 157213, 20363, 20179, 57035, 157164, 157156, 20202, 20338, 57188, 20348, 20172, 20183, 57073, 20264, 57016, 20325, 20143, 20367, 20258, 57009, 20182, 20175, 157169, 20056, 57004, 20082, 20037, 20053, 157139, 57187, 58702, 20250, 20313, 20100, 20207, 20230, 157146, 20157, 157476, 20249, 57204, 20140, 57111, 20181, 20281, 57171, 20033, 20074, 20165, 57113, 20243, 20178, 57193, 20188, 20339, 57117, 20141, 57041, 57072, 57008, 157414, 20321, 157215, 57198, 57054, 57155, 20097, 20003, 20015, 20233, 20220, 20265, 57098, 57124, 57116, 57045, 157184, 20185, 57156, 57076, 57105, 58701, 20086, 20087, 20217, 157409, 20102, 57012, 57201, 20180, 20294, 157466, 157442, 20129, 157449, 20171, 57024, 57183, 157438, and 157440.
  • Classification du dispositif
    Radiology Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Nationwide distribution: States of AL, AZ, CA, CT, DC, DE, FL, GA, IA, IL, IN, KS, KY, MA, MD, ME, MI, MN, MO, MT, NC, NE, NJ, NY, OH, OK, PA, PR, RI, SC, TN, TX, UT, VA, WA, WI, and WY.
  • Description du dispositif
    AXIOM Artis MP/Artis dMP and Artis zee Multipurpose. 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