Retiro De Equipo (Recall) de OLS-500 & OLS-700 surgical lightsAll OLS500/OLS700 lights manufactured and installed since January 2015 may be affected.

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

¿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-00989-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2015-10-07
  • País del evento
  • Fuente del evento
    DHTGA
  • URL de la fuente del evento
  • 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
    Claveguard ols-500 & ols-700 surgical lights manufactured since january 2015 have potential for the locating pin on the light handle to become detached in the event the restraining grub screw works loose.
  • Acción
    Dickson & Dickson Healthcare are inspecting all affected systems to ensure the correct installation of the locating pin and perform any corrections required. This action has been closed-out on 18/08/2016.

Device

  • Modelo / Serial
    OLS-500 & OLS-700 surgical lightsAll OLS500/OLS700 lights manufactured and installed since January 2015 may be affected. ARTG Number: 198978
  • Manufacturer

Manufacturer

  • Source
    DHTGA