Events

Retiro De Equipo (Recall) de Fujifilm MS Swivel Arm

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-2017-RN-00961-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2017-08-08
  • 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-00961-1
  • 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
    Fujifilm has become aware of a potential issue with the fujifilm ms (mammography system) swivel arm. it was found that in one case, the coupling key connecting the ball screw and the motor for moving the swivel arm up/down of the fdr ms-3500 was removed, causing the swivel arm to move downwards. whilst the probability of this occurring is considered to be very low, fujifilm wishes to reduce any potential risk to patients by undertaking this action.
  • Acción
    Fujifilm is requesting that: 1. Once a Fujifilm engineer has checked and tightened the coupling key, users will need to complete the Customer Feedback form supplied with the original Customer Letter and return it by post, fax or email as per the instructions given.

Device

Fujifilm MS Swivel Arm
  • Modelo / Serial
    Fujifilm MS Swivel ArmSerial Numbers:MS-3500 (76221095 or earlier)MS-2500 (Made in Japan - 16640001 or later)MS-2500 (Made in China - 26860001 or later)MS-2000 (Made in Japan - 16650001 or later)MS-2000 (Made in China - 26870001 or later)
  • Manufacturer
    Fujifilm Australia Pty Ltd

Manufacturer

Fujifilm Australia Pty Ltd