Events

Rappel de Fujifilm MS Swivel Arm

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-2017-RN-00961-1
  • Classe de risque de l'événement
    Class II
  • Date de mise en oeuvre de l'événement
    2017-08-08
  • 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-00961-1
  • 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 become aware of a potential issue with the fujifilm ms (mammography system) swivel arm. it was found that in one case, the coupling key connecting the ball screw and the motor for moving the swivel arm up/down of the fdr ms-3500 was removed, causing the swivel arm to move downwards. whilst the probability of this occurring is considered to be very low, fujifilm wishes to reduce any potential risk to patients by undertaking this action.
  • Action
    Fujifilm is requesting that: 1. Once a Fujifilm engineer has checked and tightened the coupling key, users will need to complete the Customer Feedback form supplied with the original Customer Letter and return it by post, fax or email as per the instructions given.

Device

Fujifilm MS Swivel Arm
  • Modèle / numéro de série
    Fujifilm MS Swivel ArmSerial Numbers:MS-3500 (76221095 or earlier)MS-2500 (Made in Japan - 16640001 or later)MS-2500 (Made in China - 26860001 or later)MS-2000 (Made in Japan - 16650001 or later)MS-2000 (Made in China - 26870001 or later)
  • Manufacturer
    Fujifilm Australia Pty Ltd

Manufacturer

Fujifilm Australia Pty Ltd