Events

Rappel de Medtronic Navigation O-Arm Imaging System (Digital fluoroscopic diagnostic portable x-ray system)

Selon Department of Health, Therapeutic Goods Administration, ce/cet/cette rappel concerne un dispositif en/au/aux/à Australia qui a été fabriqué par Medtronic Australasia Pty Ltd.

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
    RC-2013-RN-00106-1
  • Classe de risque de l'événement
    Class I
  • Date de mise en oeuvre de l'événement
    2013-02-05
  • Pays de l'événement
    Australia
  • Source de l'événement
    DHTGA
  • URL de la source de l'événement
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2013-RN-00106-1
  • Notes / Alertes
    Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, except for the categories Manufacturer Parent Company and Product Classification.
    The Parent Company and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Australia.
  • Notes supplémentaires dans les données
  • Cause
    Medtronic has identified a potential failure in the braking system that controls the o-arm gantry’s vertical movement. medtronic's internal investigation identified that the transistor which is part of the motion control box that manages the gantry’s vertical movement, could be exposed to a level of current that would damage it and could cause it to fail. if the transistor fails, the brake that holds the gantry in its vertical position could release, allowing the gantry to rapidly descend.
  • Action
    The manufacturer, Medtronic navigation has identified a correction for this potential failure mode by designing and implementing an improved circuit for the braking system that controls the O-Arm gantry’s vertical movement. Medtronic is advising customers to set the OR table/patient height from the floor as low as possible to reduce the risk of adverse health consequence in the unlikely event of the failure mode occurring in the field until affected systems are implemented with the corrective action.

Device

Medtronic Navigation O-Arm Imaging System (Digital fluoroscopic diagnostic portable x-ray system)
  • Modèle / numéro de série
    Medtronic Navigation O-Arm Imaging System (Digital fluoroscopic diagnostic portable x-ray system)Serial Numbers: 101 - 564ARTG Number: 135566
  • Classification du dispositif
    Radiology Devices
  • Manufacturer
    Medtronic Australasia Pty Ltd

Manufacturer

Medtronic Australasia Pty Ltd
  • Société-mère du fabricant (2017)
    Medtronic plc
  • Commentaire du fabricant
    “If our surveillance systems identify a potential performance issue, our personnel promptly evaluate the problem, including, when appropriate, conducting root cause investigations and internal testing to assess whether the product continues to meet specifications and defined performance criteria,” Medtronic told ICIJ in a statement. “In some cases, based on this evaluation, Medtronic may determine that a recall is necessary.” The company said that it communicates with healthcare providers and/or patients and provide recommendations to address such issues. Medtronic noted that these communications can include letters, emails, calls, press releases, physician notifications and social media postings, as well as informing the FDA and other regulators of the actions.
  • Source
    DHTGA