Events

Rappel de TBS iNsight v. 3.0.1 (software installed on bone densitometers for estimating fracture risk)

Selon Department of Health, Therapeutic Goods Administration, ce/cet/cette rappel concerne un dispositif en/au/aux/à Australia qui a été fabriqué par Inovanz 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-2016-RN-01358-1
  • Classe de risque de l'événement
    Class II
  • Date de mise en oeuvre de l'événement
    2016-10-21
  • 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-2016-RN-01358-1
  • 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 has been identified that the frax adjusted for tbs values are not correct when the frax feature is activated in tbs insight and tbs has been computed from a spine scan where some vertebrae were excluded. this does not affect the trabecular bone scores. patient fracture risk evaluations could be altered based on this issue.
  • Action
    Inovanz has advised users of a new software version, v.3.0.2, that is available and incorporates a permanent fix for this issue. In the interim, Inovanz has advised users to immediately deactivate the FRAX adjusted for TBS feature. In addition, a tool is being provided that will automatically analyse and provide a detailed report for all erroneous fracture risk evaluations with v.3.0.1. This action has been closed-out on 24/05/2017.

Device

TBS iNsight v. 3.0.1 (software installed on bone densitometers for estimating fracture risk)
  • Modèle / numéro de série
    TBS iNsight v. 3.0.1 (software installed on bone densitometers for estimating fracture risk)ARTG Number: 227987
  • Manufacturer
    Inovanz Pty Ltd

Manufacturer

Inovanz Pty Ltd
  • Source
    DHTGA