Events

Rappel de FREEDOM EVO 200

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

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
    109026
  • Classe de risque de l'événement
    II
  • Date de mise en oeuvre de l'événement
    2015-05-11
  • 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
    Tecan detected a software bug that manifests itself when a specific set of conditions are met. this results in the door locks unlocking potentially allowing access for an operator to reach in while the arms are moving. this could potentially cause an injury to the operator if they are physically inside the freedom evo's working area during arm movement.

Device

FREEDOM EVO 200
  • Modèle / numéro de série
    Model Catalog: 10641200 (Lot serial: 1310005125); Model Catalog: 30020020 (Lot serial: 810004015); Model Catalog: 30020020 (Lot serial: 1310005125); Model Catalog: 10641200 (Lot serial: 1307003117); Model Catalog: 10641200 (Lot serial: 810004015); Model Catalog: 30020020 (Lot serial: 1307003117); Model Catalog: 10641200 (Lot serial: 810004019); Model Catalog: 30020020 (Lot serial: 810004019); Model Catalog: 30020015 (Lot serial: 1303000035); Model Catalog: 10641150 (Lot serial: 1303000035); Model Catalog: 30087806 (Lot serial: 1303000035); Model Catalog: 30020015 (Lot serial: 911002918); Model Catalog: 30087806 (Lot serial: 1307000975); Model Catalog: 30087806 (Lot serial: 911002918); Model Catalog: 30020015 (Lot serial: 1307000975); Model Catalog: 10641150 (Lot serial: 1307000975); Model Catalog: 10641150 (Lot serial: 911002918); Model Catalog: 10641100 (Lot serial: 1402002590); Model Catalog: 30020010 (Lot serial: 1408005343); Model Catalog: 10641100 (Lot serial: 1408005343); Model Catalog: 30020010 (Lot s
  • Description du dispositif
    FREEDOM EVO 200
  • Manufacturer
    TECAN US

Manufacturer

TECAN US
  • Adresse du fabricant
    MORRISVILLE
  • Société-mère du fabricant (2017)
    Tecan Group AG
  • Source
    HC