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
    147670
  • Classe de risque de l'événement
    II
  • Date de mise en oeuvre de l'événement
    2014-12-03
  • 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
    The products affected by this recall are the innova e4 washer-disinfectors manufactured by scican gmbh. this recall is being initiated as a result of a recent service of 4 units at one location which identified that the insert spacer on the lower loading rack of the trolley had come off 3 of the 4 units. this insert spacer is located on the trolley where flexible scopes are loaded. when this trolley is inserted into the unit this component slides a mechanism aside that blocks the flow of water and chemical when the trolley is not in place. without this component in place there is nothing to slide the mechanism aside and therefore no flow of chemical to reprocess the scope. while there have been no other reports of this nature it was imperative that all innova e4 units be inspected to ensure that the fitting is securely in place.

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