Events

Rappel de Multiple Allura systems(Fluoroscopic x-ray systems)

Selon Department of Health, Therapeutic Goods Administration, ce/cet/cette rappel concerne un dispositif en/au/aux/à Australia qui a été fabriqué par Philips Electronics Australia Ltd.

Qu'est-ce que c'est?

Une correction ou un retrait opéré par un fabricant afin de répondre à un problème causé par un dispositif médical. Les rappels surviennent lorsqu'un dispositif médical est défectueux, lorsqu'il pourrait poser un risque pour la santé, ou les deux à la fois.

En savoir plus sur les données ici
  • Type d'événement
    Recall
  • ID de l'événement
    RC-2015-RN-00604-1
  • Classe de risque de l'événement
    Class I
  • Date de mise en oeuvre de l'événement
    2015-07-02
  • Pays de l'événement
    Australia
  • Source de l'événement
    DHTGA
  • URL de la source de l'événement
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2015-RN-00604-1
  • Notes / Alertes
    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.
  • Notes supplémentaires dans les données
  • Cause
    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.
  • Action
    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)
  • Modèle / numéro de série
    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
  • Classification du dispositif
    Radiology Devices
  • Manufacturer
    Philips Electronics Australia Ltd

Manufacturer

Philips Electronics Australia Ltd
  • Société-mère du fabricant (2017)
    Philips
  • Source
    DHTGA