Events

Rappel de INNOVA E4 WASHER - DISINFECTOR

Selon Health Canada (via FOI), ce/cet/cette rappel concerne un dispositif en/au/aux/à Canada qui a été fabriqué par SCICAN 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
    16777
  • Classe de risque de l'événement
    II
  • Date de mise en oeuvre de l'événement
    2016-03-16
  • 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
    A hospital contacted scican on march 10 2016 to report difficulties with one of their e4-wd washer-disinfectors. the hospital's biomedical technician reported that he identified the upper water flap of one channel being stuck in the closed position. according to the hospital's biomedical technician a screw securing the water flap was suspected to be responsible for this issue. that specific screw was apparently loose and deflected the stainless steel insert spacer from its normal position causing it to miss the water flap which consequently remained closed. as the water flap was stuck in the closed position it did not allow the proper circulation of water and chemicals in the upper scope. the scopes located in that specific location were not reprocessed correctly. the biomedical technician has confirmed that this water flap was opening correctly until march 9th 2016.

Device

INNOVA E4 WASHER - DISINFECTOR
  • Modèle / numéro de série
    Model Catalog: E4-WD (Lot serial: >10 NUMBERS CONTACT MFG)
  • Description du dispositif
    INNOVA E4 WASHER-DISINFECTOR
  • Manufacturer
    SCICAN LTD.

Manufacturer

SCICAN LTD.
  • Adresse du fabricant
    TORONTO
  • Société-mère du fabricant (2017)
    Scican Ltd
  • Source
    HC