Events

Retiro De Equipo (Recall) de Philips Ingenuity Core (728321)

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-00312-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2018-04-12
  • 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-00312-1
  • 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 has identified systems that may have been infected with the "wannacry" ransomware virus before installation. the virus may encrypt files in a way that:- prevents system access; or - a patient undergoing a scan or recently scanned whose results have not been reviewed may require a ct rescan; or- during a biopsy the system may be slowed such that the operator is unable to visualise the advancement of a biopsy needle in real timeto date, there have been no reports of patient harm as a result of this issue.
  • Acción
    Philips are advising that they will be contacting users to arrange an appointment for a Field Service Engineer to correct the software on any potentially impacted systems

Device

Philips Ingenuity Core (728321)
  • Modelo / Serial
    Philips Ingenuity Core (728321)Serial Numbers: 333166, 333170, 333171, 333173-333181, 333184 ARTG Number: 98868(Philips Electronics Australia - X-ray system, diagnostic, computed tomography, full-body)
  • Manufacturer
    Philips Electronics Australia Ltd

Manufacturer

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