Events

Retiro De Equipo (Recall) de cobas 8000 core unit

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 Roche Diagnostics GmbH.

¿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
    21713
  • Fecha de inicio del evento
    2017-07-25
  • 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 Consumer Health, Division of Roche Products (NZ) Limited, 8 Henderson Place, Te Papapa, AUCKLAND
  • Causa
    A software issue has been identified, which in rare cases resets the system configuration of the control unit software to "default"., the issue may occur during initialisation of the system setting information database. if a reading failure occurs any of the following symptoms can be identified:, 1. the date and time in the status line on screen is not displayed., 2. the information about the "analytical unit" (au) is not displayed in the data review screen - but is displayed in test review., 3. the year/month/date/time of the printout preview on the history screen is not displayed., 4. cu settings under utility-system are set to "default".
  • Acción
    Manufacturer to issue advice regarding use

Device

cobas 8000 core unit
  • Modelo / Serial
    Model: , Affected: Software versions 05-02, 06-02 and 06-03
  • Manufacturer
    Roche Diagnostics GmbH

Manufacturer

Roche Diagnostics GmbH