Events

Retiro De Equipo (Recall) de Roche Virtuoso software

Según New Zealand Medicines and Medical Devices Safety Authority, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en New Zealand que fue producido por manufacturer #1479.

¿Qué es esto?

Una corrección al equipo o acción de retiro tomada por el fabricante para abordar un problema con un dispositivo médico. Los retiros (recalls) ocurren cuando un dispositivo médico está defectuoso, cuando puede poner en riesgo la salud, o cuando simultáneamente está defectuoso y puede poner en riesgo la salud.

Más información acerca de la data acá
  • Tipo de evento
    Recall
  • ID del evento
    19259
  • Fecha de inicio del evento
    2015-10-19
  • País del evento
    New Zealand
  • Fuente del evento
    NZMMDSA
  • URL de la fuente del evento
    https://medsafe.govt.nz/hot/Recalls/RecallSearch.asp
  • Notas / Alertas
    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.
  • Notas adicionales en la data
    Recalling Organisation: Roche Diagnostics (NZ) Ltd, 15 Rakino Way, Mt Wellington, AUCKLAND 1644
  • Causa
    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.
  • Acción
    Software to be upgraded

Device

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

Manufacturer

manufacturer #1479