Events

Rappel de Roche Virtuoso software

Selon New Zealand Medicines and Medical Devices Safety Authority, ce/cet/cette rappel concerne un dispositif en/au/aux/à New Zealand qui a été fabriqué par manufacturer #1479.

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
    19259
  • Date de mise en oeuvre de l'événement
    2015-10-19
  • Pays de l'événement
    New Zealand
  • Source de l'événement
    NZMMDSA
  • URL de la source de l'événement
    https://medsafe.govt.nz/hot/Recalls/RecallSearch.asp
  • Notes / Alertes
    Data from New Zealand is current through July 2018. All of the data comes from the New Zealand Medicines and Medical Devices Safety Authority, 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 New Zealand.
  • Notes supplémentaires dans les données
    Recalling Organisation: Roche Diagnostics (NZ) Ltd, 15 Rakino Way, Mt Wellington, AUCKLAND 1644
  • Cause
    The iscan coreo or ventana iscan ht scans slides at 4x, 10x, 20x, or 40x magnifications. for images scanned at 4x, 10x, and 40x magnification in v5.4 and v5.5, the linear and area measurement tools display a value that is 1/5, 1/2 and 2x the actual measurement, respectively. the measurement will be displayed incorrectly regardless of what magnification the image is viewed at., customers who have used the measurement tool for slides that were scanned at 4x, 10x, or 40x to assist with a diagnosis, need to be aware that an incorrect estimation of clinical stage could lead to improper treatment., for images that are scanned at 20x magnification, the measurement tools work properly in all versions of virtuoso including versions 5.4 and 5.5.
  • Action
    Software to be upgraded

Device

Roche Virtuoso software
  • Modèle / numéro de série
    Model: 07299303001 (V5.4), 07072984001 (V5.5), Affected: , Software version: 5.4 and 5.5
  • Manufacturer
    manufacturer #1479

Manufacturer

manufacturer #1479