Events

Retiro De Equipo (Recall) de CellaVision DI-60 version 6.0.1 and 6.0.2

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 Sysmex Corporation.

¿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
    22936
  • Fecha de inicio del evento
    2018-05-07
  • 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
    A bug has been discovered in versions 6.0.1 and 6.0.2 of cellavision di-60 software where some comments are not sent to lis., the problem occurs only when a specific workflow involving multi-slide is selected as described below:, a)multiple slide workflow is selected (i.E. > 1 slide is analyzed on a sample no.), and, b)operator adds a comment on the last slide in the wbc, rbc or plt comment boxes in the di-60 sw after it has been signed/reported.
  • Acción
    Software to be upgraded

Device

CellaVision DI-60 version 6.0.1 and 6.0.2
  • Modelo / Serial
    Model: All on sw version 6.0.1 and 6.0.2., Affected:
  • Manufacturer
    Sysmex Corporation

Manufacturer

Sysmex Corporation