Events

Retiro De Equipo (Recall) de DigitalDiagnost Release 3.1.x

Según Department of Health, Therapeutic Goods Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Australia que fue producido por Philips Electronics Australia 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-00644-1
  • Clase de Riesgo del Evento
    Class III
  • Fecha de inicio del evento
    2017-05-18
  • 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-00644-1
  • 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
    Philips healthcare has identified a firmware anomaly inside the detector (4343rc) that can cause the detector to appear ready for acquisition at very short time intervals while it actually is not, resulting in incorrectly acquired x-ray images. a retake of the image is necessary if the captured corrupt image is clinically unusable, leading to additional exposure for the patient.
  • Acción
    Philips will be installing a software upgrade in affected systems as a permanent fix to this issue. Users are advised that they will be contacted by a Service Engineer when the upgrade is available to be implemented. In the interim, users are to note if the problem occurs, they may see an underexposed image and the clinician may decide to conduct a repeat exposure. Users are advised that the system can be used according to the Instructions for Use (IFU) and to contact Philips if they have any questions.

Device

DigitalDiagnost Release 3.1.x

Manufacturer

Philips Electronics Australia Ltd
  • Empresa matriz del fabricante (2017)
    Philips
  • Source
    DHTGA