Events

Retiro De Equipo (Recall) de Synapse Cardiovascular (CV) Software

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-2018-RN-00504-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2018-06-20
  • 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-2018-RN-00504-1
  • 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
    Fujiflm has become aware of a malfunction in the system where inconsistent mitral valve mean pressure gradient values are being reported. the values are only affected when measuring multiple velocity traces in patients with an irregular heart rhythm, with mitral and tricuspid valve stenosis, using the synapse cv measurement tools. multiple traces measured on the modality and transmitted to synapse cv are not affected.To date, there have been no reported patient injuries as a result of this issue. this malfunction does not impact the advances reporting system and there have been no reports of any other measurements or calculations being affected.
  • Acción
    Fujifilm is advising users not to perform sequential multiple velocity trace measurements for mitral, tricuspid, aortic or pulmonic valves in the Synapse Cardiovascular analysis package. If averaging needs to be performed in Synapse Cardiovascular analysis package, users are advised to follow the steps outlined in the Customer Letter. This issue has been corrected in Synapse CV 6.1.0 and higher versions

Device

Synapse Cardiovascular (CV) Software
  • Modelo / Serial
    Synapse Cardiovascular (CV) SoftwareSoftware versions 4.0.2 to 6.0.4.1ARTG Number: 164422(Fujifilm Australia Pty Ltd - Picture archiving and communication system, software)
  • Manufacturer
    Fujifilm Australia Pty Ltd

Manufacturer

Fujifilm Australia Pty Ltd