Events

Rappel de DigitalDiagnost Release 3.1.x

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-00848-1
  • Classe de risque de l'événement
    Class II
  • Date de mise en oeuvre de l'événement
    2017-07-07
  • 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-00848-1
  • 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 healthcare has identified a firmware anomaly inside the detector (4343rc) that can cause the detector to appear ready for acquisition at very short time intervals while it actually is not, resulting in incorrectly acquired x-ray images. a retake of the image is necessary if the captured corrupt image is clinically unusable, leading to additional exposure for the patient.
  • Action
    Philips is requesting that users: -Read the supplied notice. -Distribute the supplied notice to all users of the device in your facility. -Complete the response form and return it to Philips via fax/email within 3 business days as per the instructions in the customer letter. Philips plans to install a software upgrade in affected systems, which will eliminate this issue. A Philips Service Engineer will contact users when the Field Action Kit is available to be implemented. Should users need to communicate with Philips with regard to this matter, reference Field Change Order 71200170.

Device

DigitalDiagnost Release 3.1.x

Manufacturer

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