Events

Retiro De Equipo (Recall) de CLARUS 500 with Software versions: 1.0.0, 1.0.1 and 1.0.2

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-2018-RN-00350-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2018-04-27
  • 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-2018-RN-00350-1
  • 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
    It has been identified that it is possible for the clarus 500 to allocate patient data to the wrong patient. this may occur when the operator exits the acquire page to the patient management page while the system is in process of creating the montage of two or more images. the constituent images from which the montage is derived are still assigned to the correct patient. they can be viewed individually or manually montaged to recreate the missing information. the error is detectable as there will be no constituent image to support the montage for the affected patient.
  • Acción
    Zeiss will be conducting a software update by the ZEISS Service Centre and important changes to the User Manual for CLARUS 500 which has already been supplied to users. A software update is available for the CLARUS 500 and updated user manual is available accordingly. The update only applies to CLARUS 500 devices with software versions 1.0.0, 1.0.1, and 1.0.2.

Device

CLARUS 500 with Software versions: 1.0.0, 1.0.1 and 1.0.2
  • Modelo / Serial
    CLARUS 500 with Software versions: 1.0.0, 1.0.1 and 1.0.2ARTG Number: 295240Carl Zeiss - Camera, fundus
  • Manufacturer
    Carl Zeiss Pty Ltd

Manufacturer

Carl Zeiss Pty Ltd