Events

Recall of Roche Virtuoso software

According to New Zealand Medicines and Medical Devices Safety Authority, this recall involved a device in New Zealand that was produced by manufacturer #1479.

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    19259
  • Event Initiated Date
    2015-10-19
  • Event Country
    New Zealand
  • Event Source
    NZMMDSA
  • Event Source URL
    https://medsafe.govt.nz/hot/Recalls/RecallSearch.asp
  • Notes / Alerts
    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.
  • Extra notes in the data
    Recalling Organisation: Roche Diagnostics (NZ) Ltd, 15 Rakino Way, Mt Wellington, AUCKLAND 1644
  • Reason
    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
  • Model / Serial
    Model: 07299303001 (V5.4), 07072984001 (V5.5), Affected: , Software version: 5.4 and 5.5
  • Manufacturer
    manufacturer #1479

Manufacturer

manufacturer #1479