Events

Rappel de All Welch Allyn KleenSpec Corded Illumination Systems (used in conjunction with the KleenSpec Disposable Vaginal Specula)

Selon Department of Health, Therapeutic Goods Administration, ce/cet/cette rappel concerne un dispositif en/au/aux/à Australia qui a été fabriqué par Welch Allyn Australia Pty 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
    RC-2015-RN-01030-1
  • Classe de risque de l'événement
    Class II
  • Date de mise en oeuvre de l'événement
    2015-10-26
  • Pays de l'événement
    Australia
  • Source de l'événement
    DHTGA
  • URL de la source de l'événement
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2015-RN-01030-1
  • Notes / Alertes
    Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, 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 Australia.
  • 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. this may result in a shattered lamp 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 laptops, and other medical devices that have similar power cord connector.
  • Action
    Welch Allyn is providing users with additional labelling to place on the cords to remind users to only connect the Illuminator with the corresponding corded wall transformer. This action has been closed-out on 22/08/2016.

Device

All Welch Allyn KleenSpec Corded Illumination Systems (used in conjunction with the KleenSpec Dis...
  • Modèle / numéro de série
    All Welch Allyn KleenSpec Corded Illumination Systems (used in conjunction with the KleenSpec Disposable Vaginal Specula)Model Numbers: 78810, 78812, 78814 and 78816Lot Numbers: AllARTG Number: 101442
  • Manufacturer
    Welch Allyn Australia Pty Limited

Manufacturer

Welch Allyn Australia Pty Limited