Events

Retiro De Equipo (Recall) de Fujifilm Synapse PACS software version 4.0, 4.1, 4.2, 4.3 (a picture archiving and communication 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-2016-RN-01329-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2017-11-20
  • 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-2016-RN-01329-1
  • 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
    An issue has been identified with the image processing software module when two or more patient fcr images (fuji computed radiology images stored in a proprietry format) from synapse pacs are sent simultaneously to another manufacturer's pacs . when fcr images (comprised of pixel data and the dicom header) are sent via cmove or forwarded by ebf (event based forwarding) on multiple associations simultaneously, in rare situations, one or more of the following issues can happen: a) patient a’s pixel data is changed to patient b’s pixel data and forwarded to the destination. b) the output image is corrupted and may appear as random noise. c) dicomserver crashes. if issue a) or b) happens, only the image in the destination archive is affected. images in the source synapse system are not affected. the potential risk is that pixel data for a patient’s image may not be correct in the destination (non-fujifilm) pacs. however, the radiology reports will be correct.
  • Acción
    Fujifilm has applied a corrective software patch to affected PACS as a permanent fix. This action has been closed-out on 20/11/2017.

Device

Fujifilm Synapse PACS software version 4.0, 4.1, 4.2, 4.3 (a picture archiving and communication ...
  • Modelo / Serial
    Fujifilm Synapse PACS software version 4.0, 4.1, 4.2, 4.3 (a picture archiving and communication system)ARTG Number: 203605
  • Manufacturer
    Fujifilm Australia Pty Ltd

Manufacturer

Fujifilm Australia Pty Ltd