Events

Retiro De Equipo (Recall) de OMNYX INTEGRATED DIGITAL PATHOLOGY SYSTEM - SOFTWARE

Según Health Canada (via FOI), este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Canada que fue producido por GENERAL ELECTRIC CANADA (OPERATING AS GE HEALTHCARE).

¿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
    21954
  • Clase de Riesgo del Evento
    III
  • Fecha de inicio del evento
    2016-07-06
  • País del evento
    Canada
  • Fuente del evento
    HC
  • Notas / Alertas
    Canadian data is current through March 2018. All of the data comes from Health Canada, 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 Canada.
  • Notas adicionales en la data
  • Causa
    Omnyx has determined that there is an issue with the digital archive (da) management tool when used with dps 1.3.0 dps 1.3.1 and dynamyx 2.0 versions software. when migrating cases to a new da the da management tool may cause images to improperly appear in the unmatched slide tab and may also change the status of the case from the current status to "awaiting scans.".

Device

OMNYX INTEGRATED DIGITAL PATHOLOGY SYSTEM - SOFTWARE
  • Modelo / Serial
    Model Catalog: OMN-10005056-X (Lot serial: N/A); Model Catalog: 10009061-X (Lot serial: N/A); Model Catalog: 10010766-X (Lot serial: N/A)
  • Descripción del producto
    OMNYX INTEGRATED DPS SOFTWARE;DYNAMYX SOFTWARE
  • Manufacturer
    GENERAL ELECTRIC CANADA (OPERATING AS GE HEALTHCARE)

Manufacturer

GENERAL ELECTRIC CANADA (OPERATING AS GE HEALTHCARE)