Events

Rappel de DuraDiagnost Release 1.0, 2.0, 3.0 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-2017-RN-00726-1
  • Classe de risque de l'événement
    Class I
  • Date de mise en oeuvre de l'événement
    2017-06-01
  • 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-2017-RN-00726-1
  • 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
    Philips has discovered via a report from the field that some welding joints on the vertical carriage brackets of the tube stand may crack. as a result, the tube arm assembly may exhibit uncharacteristic sideways movement, with the tube becoming off center. if all of the welding joints cracked, the tube arm assembly could fall down and a patient on the examination table or anyone in the vicinity could be struck by the falling tube arm assembly resulting in serious injury or death.
  • Action
    A Philips Engineer will go on-site and inspect the welding joints of the tube stand vertical carriage brackets and install the safety hooks structure, which will prevent the tube arm assembly from falling down even if all the bracket welding joints are cracked. In the interim, users are to stop using the device.

Device

DuraDiagnost Release 1.0, 2.0, 3.0 X-Ray systems
  • Modèle / numéro de série
    DuraDiagnost Release 1.0, 2.0, 3.0 X-Ray systemsDuraDiagnost R1.0 Product Number: 712210DuraDiagnost R2.0 and R3.0Product Number: 712211ARTG Number: 207424
  • Classification du dispositif
    Radiology Devices
  • Manufacturer
    Philips Electronics Australia Ltd

Manufacturer

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