Events

Retiro De Equipo (Recall) de 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-2017-RN-00903-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2017-07-25
  • 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-00903-1
  • 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 identified that in very rare cases, software versions v5.0, v5.1, v5.2, v6.0, v6.1 and v7.00 for specific workstations within the digital mammography system may possibly assign a duplicated id number to exposure images.Transmitting the image with the duplicated id number assigned to a pacs could possibly overwrite the image in an old study stored on the pacs. this would cause an unexpected image to appear when referring to the old study. the image and data of a new study does not have this issue, therefore, there is no effect on a diagnosis.Fujifilm has corrected the software that is the cause of such failure.
  • Acción
    FUJIFILM has corrected the software that is the cause of such failure. Actions to be taken by customer/user: Make sure the latest images transmitted to PACS exists in the new study-where it should be. If the image with the duplicated ID number assigned is transmitted to PACS, you will fail to find it in a newly created study. (ie it is missing). This is because the image transmitted to PACS with that error overwrites an existing(older) study image and is stored in another(older) study. If you have this error, please contact your local FUJIFILM office. Although the probability of the above error is very rare, systematically checking that the correct number of images per patient has been transferred to the PACS will make sure in case such errors occur.

Device

Fujifilm Digital Mammography System
  • Modelo / Serial
    Fujifilm Digital Mammography SystemWorkstations:Amulet (FDR MS-1000)Amulet (FDR MS-2500)Amulet Innovality (FDR MS-3500)CR-IR363AWSSoftware versions: v5.0, v5.1, v5.2, v6.0, v6.1 and v7.0 ARTG Number:159785
  • Manufacturer
    Fujifilm Australia Pty Ltd

Manufacturer

Fujifilm Australia Pty Ltd