Events

Retiro De Equipo (Recall) de KLEENSPEC CORDED ILLUMINATOR

Según Health Canada (via FOI), este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Canada que fue producido por WELCH ALLYN CANADA 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
    53008
  • Clase de Riesgo del Evento
    II
  • Fecha de inicio del evento
    2015-09-21
  • País del evento
    Canada
  • Fuente del evento
    HC
  • Notas / Alertas
    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.
  • 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 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
  • Modelo / Serial
    Model Catalog: 78810 (Lot serial: All); Model Catalog: 78800 (Lot serial: All); Model Catalog: 73410 (Lot serial: All)
  • Descripción del producto
    KleenSpec Corded Illuminator
  • Manufacturer
    WELCH ALLYN CANADA LIMITED

Manufacturer

WELCH ALLYN CANADA LIMITED