Events

Retiro De Equipo (Recall) de Philips Allura Xper X-Ray 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-2017-RN-00432-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2017-04-05
  • 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-00432-1
  • 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
    Through customer complaints, philips has discovered problem with the detector cooling system for a limited number of allura xper and allura cv20. due to a leak in the detector cooling system, cooling liquid may leak outside the drip tray of the chiller. if this occurs the liquid may drip onto electrical components in the r-cabinet located in the technical room, which could lead to damage to the system and potentially cause thermal events such as a burning odour, smoke or fire. to date, philips is not aware of any injuries that may have occurred as a result of this problem.
  • Acción
    Philips is advising users that if a burning odour, smoke or fire is detected coming from the technical room, the main switch should be turned off and system taken out of service immediately. In the event of a hazardous situation, users are requested to adhere to their workplace emergency procedures. Once any hazardous situation has been abated, users are advised to inform their local Philips representative. (Please note: Philips will start inspecting affected systems for leaks and repair as required. In addition as from April 2017, Philips will undertake a free installation of an extended drip tray on affected systems to prevent damage from any future leaks).

Device

Philips Allura Xper X-Ray Systems
  • Modelo / Serial
    Philips Allura Xper X-Ray SystemsAllura Xper and Allura CV20 Releases 3 to 8.1 with an installed Laird chillerAllura Xper Release 8.2: only configurations FD10, FD10/10, FD20/10, FD20/20 have a Laird chillerMultiple Product Names and CodesARTG Number: 225815
  • Manufacturer
    Philips Electronics Australia Ltd

Manufacturer

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