Events

Retiro De Equipo (Recall) de Multiple Allura systems(Fluoroscopic 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-2015-RN-00604-1
  • Clase de Riesgo del Evento
    Class I
  • Fecha de inicio del evento
    2015-07-02
  • 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-2015-RN-00604-1
  • 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
    Customer reported an issue with a failing monitor ceiling suspension (mcs) actuator of an allura xper system. the actuator assembly had become detached and the monitor carriage with a flexvision monitor dropped to its lowest position. the monitor ceiling suspension is designed to allow flexible positioning near the patient table when in use, and away from the patient when not in use (park position).When the monitor ceiling suspension falls to its lowest position there is a possibility it might collide with patient or personnel in the room. there is also the possibility that the monitor ceiling suspension collides with other equipment in close proximity of the mcs.
  • Acción
    Philips will check if the actuator serial number is on the affected product list. If the actuator is on the affected product list the immediate containment action is to secure the MCS with straps to prevent the monitors to fall down in case the actuator fails. Actuators on the affected products will be replaced by Philips. In order to avoid any risk for patients, users or bystanders Philips recommend the following until the containment action FCO has been implemented: - Do not position or move the Monitor Ceiling Suspension above the patient. - Do not allow staff to stand under or close to the Monitor Ceiling Suspension. Additionally avoid any unnecessary movement of the Monitor Ceiling Suspension and inform all possible System users. This action has been closed-out on 15/08/2016.

Device

Multiple Allura systems(Fluoroscopic x-ray systems)
  • Modelo / Serial
    Multiple Allura systems(Fluoroscopic x-ray systems)Systems affected:Allura Xper FD10Allura Xper FD10/10Allura Xper FD20Allura Xper FD20/10Allura Xper FD10 OR TableAllura Xper FD20 OR TableAllura Xper FD10/10 OR TableAllura Xper FD20 Biplane OR TableProduct Codes - 722010, 722011, 722012, 722013, 722022, 722023, 722024 &722025.Applies to - Actuator Short Assy: THC8AWDS-121 989600-184-665 & Actuator Long Assy: THC8AWDS-122 989600-184-654ARTG Number: 175708
  • Clasificación del producto
    Radiology Devices
  • Manufacturer
    Philips Electronics Australia Ltd

Manufacturer

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