Events

Retiro De Equipo (Recall) de FUJIFILM FDR-1000AWS / FDR-2000AWS / FDR-3000AWS V5.1.0001-0007 with Biopsy unit (a component of FUJIFILM Digital Mammography 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-2014-RN-00479-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2014-04-24
  • 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-2014-RN-00479-1
  • 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 was found that for software v5.1.0001-0007 used in workstation (aws), which is a component of fujifilm digital mammography system, when image enhancement processing is performed on the exposed image with an option function during biopsy, the screen may not return to the original image. depending on the enhancement parameter, the calcification may seem unclear compared to the original image. therefore, there is a potential that the tip of needle cannot reach the desired biopsy area. furthermore, after collecting the target sample, it may be difficult to ascertain whether the necessary calcification part has been properly extracted. due to these reasons, the occurrence of this issue may precipitate that a re-examination might be necessary. this image processing is an option for biopsy and does not affect other normal exposures.
  • Acción
    Customers are advised to not perform image enhancement during Biopsy. In the case that a calcification becomes unclear due to enhancement processing, select the weakest enhancement processing or redisplay the image on the 1st monitor by right-clicking. FUJIFILM service personnel will contact the affected facility to arrange for a software update as a corrective measure.

Device

FUJIFILM FDR-1000AWS / FDR-2000AWS / FDR-3000AWS V5.1.0001-0007 with Biopsy unit (a component of ...
  • Modelo / Serial
    FUJIFILM FDR-1000AWS / FDR-2000AWS / FDR-3000AWS V5.1.0001-0007 with Biopsy unit (a component of FUJIFILM Digital Mammography System)Serial Number: 37020038ARTG Number: 159785
  • Manufacturer
    Fujifilm Australia Pty Ltd

Manufacturer

Fujifilm Australia Pty Ltd