Events

Rappel de ROSA

Selon Health Canada (via FOI), ce/cet/cette rappel concerne un dispositif en/au/aux/à Canada qui a été fabriqué par MEDTECH S.A..

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
    121666
  • Classe de risque de l'événement
    I
  • Date de mise en oeuvre de l'événement
    2013-07-26
  • Pays de l'événement
    Canada
  • Source de l'événement
    HC
  • Notes / Alertes
    Canadian data is current through March 2018. All of the data comes from Health Canada, 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 Canada.
  • Notes supplémentaires dans les données
  • Cause
    When the rosa device is used in stereotactic surgery the "distance to target" function that is provided in "coopoerative mode" during the guidance phase can give the user an erroneous value under certain conditions. when the user requests this distance to target information via the software interface the value is displayed correctly. however if the distance to target window remains open and the robotic arm is moved the value is not automatically refreshed in the corresponding window thus the correct distance to target is not provided.

Device

ROSA
  • Modèle / numéro de série
    Model Catalog: RO (Lot serial: ALL)
  • Classification du dispositif
    Neurological Devices
  • Description du dispositif
    ROSA
  • Manufacturer
    MEDTECH S.A.

Manufacturer

MEDTECH S.A.
  • Adresse du fabricant
    MONPELLIER
  • Société-mère du fabricant (2017)
    Zimmer Biomet Holdings
  • Commentaire du fabricant
    “The safety of patients has always been, and continues to be, Zimmer Biomet’s top priority and it is our honor to be a leader in this industry for the past 90 years,” Zimmer Biomet told ICIJ in a statement. “We adhere to strict regulatory standards, and work closely with the FDA and all applicable regulatory agencies in each of our regions as part of our commitment to operating a first-rate quality management system across our global manufacturing network. The company added that it is focused on staying at the forefront of innovation and doing right by the millions of patients who rely on the company’s products.
  • Source
    HC