Events

Rappel de Allura Xper FD20 R8.2

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-00898-1
  • Classe de risque de l'événement
    Class III
  • Date de mise en oeuvre de l'événement
    2017-07-20
  • 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-00898-1
  • 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 identified that the protecting earth (pe) cable between a motion controller and the pe star point was not installed on the affected product.The lack of this aforementioned protective earth cable makes the system not compliant with the iec60601-1 standard for protective earthing, however there is no risk for patients / operators / users since the frame is connected to protective earth (pe) and the unit involved is shielded with a cover.The relevant parts are in the technical (equipment) room and therefore not accessible for patients. to date, philips is not aware of any injuries that may have occurred as result of this situation.
  • Action
    Philips is requesting customers: 1. Read the supplied notice; 2. Place the notice with the documentation of the system until this correction has been implemented; and 3. Complete the supplied response form and return it to Philips via fax/email within 3 business days of receiving the customer letter.

Device

Allura Xper FD20 R8.2

Manufacturer

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