Events

Retiro De Equipo (Recall) de VisuMax Laser

Según Department of Health, Therapeutic Goods Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Australia que fue producido por Carl Zeiss 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-2017-RN-00318-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2017-03-06
  • 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-2017-RN-00318-1
  • 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
    Based on complaints, carl zeiss has identified that in certain devices there is an increased probability of failure of the battery test circuit components of the uninterrupted power supply (ups)-module. it was reported from customers that after treatment was done and machine was switched off white smoke with choking smell came out from the ups at the rear side of the machine. there were no patient involvement and no adverse consequences associated with these complaints.
  • Acción
    The battery circuit for the UPS has been modified to make the UPS more robust. Carl Zeiss will replace all old power supplies as part of the next scheduled service activities of the VisuMax.

Device

VisuMax Laser
  • Modelo / Serial
    VisuMax LaserSerial numbers starting with 963599 up to 1157772ARTG Number: 150527
  • Manufacturer
    Carl Zeiss Pty Ltd

Manufacturer

Carl Zeiss Pty Ltd