Events

Retiro De Equipo (Recall) de ML 301 Examination Lamp

Según Department of Health, Therapeutic Goods Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Australia que fue producido por Medical & Optical Instruments Australia 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-2013-RN-00217-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2013-03-14
  • 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-2013-RN-00217-1
  • 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
    There are reports that after an average usage period of seven years fatigue failure of the plastic joint may occur. the manufacturer has become aware that a joint on the spring arm may break either during use or when the spring arm is not in operation. if the joint breaks, the spring arm falls suddenly and without hindrance. in such a case there is a high risk of injury to the patient and other persons in the immediate vicinity.
  • Acción
    End users are requested to inspect all units to determine if the swing arm has a plastic joint. If the joint is plastic the spring arm must not be used. A replacement spring arm will be provided for all affected units.

Device

ML 301 Examination Lamp

Manufacturer

Medical & Optical Instruments Australia Pty Ltd