Events

Retiro De Equipo (Recall) de FCR Go 2 (FCR-MB201) X-Ray System (Digital general purpose mobile diagnostic x-ray system)

Según Department of Health, Therapeutic Goods Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Australia que fue producido por Fujifilm 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-00089-2
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2013-02-01
  • 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-00089-2
  • 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
    Fujifilm australia has been advised that in rare cases, if the exposure conditions (kv and mas values) are changed manually on the control panel and the collimator lamp is turned on while concurrently pressing the electromagnetic break release switch on the collimator handle, the exposure settings are automatically reset to the values initially entered from the console.
  • Acción
    Users are advised to reconfirm displayed values before performing exposure. A software update will be provided to customers to correct the issue.

Device

FCR Go 2 (FCR-MB201) X-Ray System (Digital general purpose mobile diagnostic x-ray system)
  • Modelo / Serial
    FCR Go 2 (FCR-MB201) X-Ray System (Digital general purpose mobile diagnostic x-ray system)ARTG 156199
  • Manufacturer
    Fujifilm Australia Pty Ltd

Manufacturer

Fujifilm Australia Pty Ltd