Events

Retiro De Equipo (Recall) de All Welch Allyn KleenSpec Corded Illumination Systems (used in conjunction with the KleenSpec Disposable Vaginal Specula)

Según Department of Health, Therapeutic Goods Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Australia que fue producido por Welch Allyn Australia Pty Limited.

¿Qué es esto?

Una corrección al equipo o acción de retiro tomada por el fabricante para abordar un problema con un dispositivo médico. Los retiros (recalls) ocurren cuando un dispositivo médico está defectuoso, cuando puede poner en riesgo la salud, o cuando simultáneamente está defectuoso y puede poner en riesgo la salud.

Más información acerca de la data acá
  • Tipo de evento
    Recall
  • ID del evento
    RC-2015-RN-01030-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2015-10-26
  • País del evento
    Australia
  • Fuente del evento
    DHTGA
  • URL de la fuente del evento
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2015-RN-01030-1
  • Notas / Alertas
    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.
  • Notas adicionales en la data
  • Causa
    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.
  • Acción
    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...
  • Modelo / Serial
    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