Events

Retiro De Equipo (Recall) de VisuMax

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-01144-1
  • Clase de Riesgo del Evento
    Class III
  • Fecha de inicio del evento
    2017-09-04
  • 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-01144-1
  • 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 post market surveillance activities, carl zeiss has received information that in certain devices there is an increased probability of failure of the bpc board. the function of this board is to control an electrically driven mirror which adjusts the laser beam position if necessary. this design allows a position compensation in case the laser beam should drift.It has been determined that there was a deviation in the soldering process during the manufacture of two batches of the bpc board which can affect the reliability of the visumax beam pointing control subsystem.The probability of injury is extremely unlikely. any failure of the bpc board like error 0x3172 is detected by the monitoring functions of the device either during startup or before start of a treatment. in case of a system error the system test is cancelled before any treatment. if an error occurs, the device goes in a safe mode.
  • Acción
    Complete and return the supplied acknowledgement form. Carl Zeiss service staff will contact users to arrange an appointment for the BPC Board exchange.

Device

VisuMax
  • Modelo / Serial
    VisuMaxCatalogue Number: VISMAXSerial Number: 1173839ARTG Number: 150527
  • Manufacturer
    Carl Zeiss Pty Ltd

Manufacturer

Carl Zeiss Pty Ltd