Events

Rappel de KLEENSPEC CORDED ILLUMINATOR

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

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
    53008
  • Classe de risque de l'événement
    II
  • Date de mise en oeuvre de l'événement
    2015-09-21
  • 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
    Welch allyn has been made aware that the kleenspec 788 corded illuminator has the potential to be incorrectly connected to a commonly available ac power cord instead of the illuminator low voltage transformer power cord which is supplied with the illuminator. this may result in a shattered lamp bulb and a potential electric shock hazard. commonly available ac line power cords do not have an integrated wall transformer and therefore the electrical current from the outlet is fully transferred into the device. there have been no associated injuries but the misconnection can be reproduced. for example the illuminator cord connector may fit into ac power cords from common consumer equipment such as laptop computers and other medical devices that have similar power cord connector.

Device

KLEENSPEC CORDED ILLUMINATOR
  • Modèle / numéro de série
    Model Catalog: 78810 (Lot serial: All); Model Catalog: 78800 (Lot serial: All); Model Catalog: 73410 (Lot serial: All)
  • Description du dispositif
    KleenSpec Corded Illuminator
  • Manufacturer
    WELCH ALLYN CANADA LIMITED

Manufacturer

WELCH ALLYN CANADA LIMITED