Events

Rappel de Philips BV25, BV300, BV Libra, BV Endura, BV Pulsera (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-2016-RN-01183-1
  • Classe de risque de l'événement
    Class III
  • Date de mise en oeuvre de l'événement
    2016-09-13
  • 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-2016-RN-01183-1
  • 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 been notified regarding an issue with the x-ray "on" label for systems supplied in south australia. the colour of the exposure indicator on the control panel is same as the background text. hence, systems do not meet south australia's radiation protection and control regulation.This issue has been evaluated for radiation hazard and concluded that there is no safety impact to the patient, user or bystander. it is a regulatory non-compliance issue in south australia. this issue has been evaluated for potential radiation hazard and concluded that there is no safety impact to the patient, user or bystander.
  • Action
    Philips will be applying a red transparent label over the existing x-ray symbol on the control panel as a permanent correction in the affected systems in South Australia. In the interim, users are advised that there is an indicator lamp on Mobile Viewing Station which glows whenever x-ray exposure happens. The user should use this indication to be able to know when an exposure happens. This action has been closed-out on 24/05/2017.

Device

Philips BV25, BV300, BV Libra, BV Endura, BV Pulsera (Fluoroscopic x-ray systems)
  • Modèle / numéro de série
    Philips BV25, BV300, BV Libra, BV Endura, BV Pulsera (Fluoroscopic x-ray systems)System: BV25Model Number: 718015System: BV300Model Numbers: 71815, 71816, 71819System: BV LibraModel Numbers: 718022, 718030, 718031System: BV EnduraModel Numbers: 718071, 718072, 718073, 718074System: BV PulseraModel Number: 718094ARTG Number: 98556
  • Manufacturer
    Philips Electronics Australia Ltd

Manufacturer

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