Events

Retiro De Equipo (Recall) de ProGrade Rel.1x Systems

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-2018-RN-00135-1
  • Clase de Riesgo del Evento
    Class III
  • Fecha de inicio del evento
    2018-02-12
  • 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-00135-1
  • 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
    If the wifi connection between the skyplate detector and hp transfer point is weak, an image may fail to transfer from the skyplate detector to the system. the image remains in the memory of the detector, but cannot be transferred wirelessly or by use of the backup cable. to continue, the operator can reset the skyplate detector by removing its batteries, but the acquired image is lost and a re-take is necessary.
  • Acción
    Philips plans to release a new HP firmware to the installed base. In addition the existing Access Point Hardware in the field needs to be patched. A Philips Service Engineer will contact users when the Field Action Kit is available to be implemented.

Device

ProGrade Rel.1x Systems

Manufacturer

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