Events

Rappel de AERONEB PRO-X - CONTROLLER KIT

Selon Health Canada (via FOI), ce/cet/cette rappel concerne un dispositif en/au/aux/à Canada qui a été fabriqué par AEROGEN 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
    25407
  • Classe de risque de l'événement
    II
  • Date de mise en oeuvre de l'événement
    2014-09-05
  • 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
    Aerogen has received a small number of complaints in relation to the mains power adapter manufactured by friwo gmbh and used in the aeroneb solo and pro nebuliser systems. the complaints received identified that the power adapter cover had broken and dislodged from the body of the adapter prior to use. however it cannot be ruled out that the adapter may fail during use. if the failure was to occur during use then the internal electrical components of the mains power adapter would become exposed to the user. therefore there is a potential risk of electric shock if the cover falls off during use with mains power turned on and the user makes contact with specific recessed components inside the adapter housing.

Device

AERONEB PRO-X - CONTROLLER KIT
  • Modèle / numéro de série
    Model Catalog: AG-PX1000-US (Lot serial: N/A); Model Catalog: AG-AP1040-US (Lot serial: N/A)
  • Description du dispositif
    AERONEB PRO X CONTROLLER
  • Manufacturer
    AEROGEN LTD

Manufacturer

AEROGEN LTD
  • Adresse du fabricant
    DANGAN
  • Société-mère du fabricant (2017)
    Aerogen Ltd.
  • Source
    HC