Events

Retiro De Equipo (Recall) de Allura Xper Systems with an attached 7th or 8th monitor Multiple System Codes

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-00071-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2018-01-19
  • 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-00071-1
  • 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 been made aware of a mounting issue with the 7th or 8th monitor to the monitor ceiling suspension. the 7th or 8th monitor attached to the monitor ceiling suspension may disengage from the suspension arm and fall down.Only allura xper systems with an attached 7th or 8th monitor on the monitor ceiling suspension are affected.When a 7th or 8th monitor disengages from the suspension arm it could pose a risk for the patient, user, bystander or service engineer.
  • Acción
    Philips will be in contact with all potentially affected users and arrange for the set screws to be secured.

Device

Allura Xper Systems with an attached 7th or 8th monitor Multiple System Codes
  • Modelo / Serial
    Allura Xper Systems with an attached 7th or 8th monitor Multiple System CodesARTG Number: 225815 (Philips Electronics Australia Ltd - X-ray system, diagnostic, fluoroscopic, angiographic, stationary, digital)
  • Manufacturer
    Philips Electronics Australia Ltd

Manufacturer

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