Events

Rappel de FUJIFILM General X-ray System FDR Smart f series

Selon Department of Health, Therapeutic Goods Administration, ce/cet/cette rappel concerne un dispositif en/au/aux/à Australia qui a été fabriqué par Fujifilm Australia Pty 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-2018-RN-00351-1
  • Classe de risque de l'événement
    Class II
  • Date de mise en oeuvre de l'événement
    2018-04-23
  • 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-2018-RN-00351-1
  • 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
    Fujifilm has identified that fdr smart f systems should have been sold and installed with the stated condition of:“operation in the shielded room over 20 db radiated emission attenuation”. the units have been sold with no such condition being stated.
  • Action
    Fujifilm are advising service personnel will contact all of the medical facilities where the applicable products have been installed to arrange for this correction and visit to take corrective measures. Correction will include the addition of ferrite cores, cable shielding and replacement of internal hardware and a firmware update.

Device

FUJIFILM General X-ray System FDR Smart f series
  • Modèle / numéro de série
    FUJIFILM General X-ray System FDR Smart f seriesARTG Number: 197063Fujifilm Australia - X-ray system, diagnostic, general-purpose, stationary, analogue
  • Manufacturer
    Fujifilm Australia Pty Ltd

Manufacturer

Fujifilm Australia Pty Ltd