Events

Rappel de FUJIFILM FDR-1000AWS / FDR-2000AWS / FDR-3000AWS V5.1.0001-0007 with Biopsy unit (a component of FUJIFILM Digital Mammography System)

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-2014-RN-00479-1
  • Classe de risque de l'événement
    Class II
  • Date de mise en oeuvre de l'événement
    2014-04-24
  • 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-2014-RN-00479-1
  • 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
    It was found that for software v5.1.0001-0007 used in workstation (aws), which is a component of fujifilm digital mammography system, when image enhancement processing is performed on the exposed image with an option function during biopsy, the screen may not return to the original image. depending on the enhancement parameter, the calcification may seem unclear compared to the original image. therefore, there is a potential that the tip of needle cannot reach the desired biopsy area. furthermore, after collecting the target sample, it may be difficult to ascertain whether the necessary calcification part has been properly extracted. due to these reasons, the occurrence of this issue may precipitate that a re-examination might be necessary. this image processing is an option for biopsy and does not affect other normal exposures.
  • Action
    Customers are advised to not perform image enhancement during Biopsy. In the case that a calcification becomes unclear due to enhancement processing, select the weakest enhancement processing or redisplay the image on the 1st monitor by right-clicking. FUJIFILM service personnel will contact the affected facility to arrange for a software update as a corrective measure.

Device

FUJIFILM FDR-1000AWS / FDR-2000AWS / FDR-3000AWS V5.1.0001-0007 with Biopsy unit (a component of ...
  • Modèle / numéro de série
    FUJIFILM FDR-1000AWS / FDR-2000AWS / FDR-3000AWS V5.1.0001-0007 with Biopsy unit (a component of FUJIFILM Digital Mammography System)Serial Number: 37020038ARTG Number: 159785
  • Manufacturer
    Fujifilm Australia Pty Ltd

Manufacturer

Fujifilm Australia Pty Ltd