Events

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

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
    31577
  • Clase de Riesgo del Evento
    II
  • Fecha de inicio del evento
    2015-11-20
  • 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
    During internal evaluations omnyx became aware that variations in immunohistochemically (ihc) stained slide images may result from slides scanned with a limited number of idp vl120 scanners. further investigation determined that the installed scanner may have been manufactured with an out-of-specification led assembly. there have been no reported adverse events associated with this issue.

Device

OMNYX INTEGRATED DIGITAL PATHOLOGY SYSTEM - ROUTINE PATHOLOGY APPLICATION
  • Modelo / Serial
    Model Catalog: OMN-10005072-X (Lot serial: DSAT00103); Model Catalog: OMN-10005072-X (Lot serial: DSAT00104); Model Catalog: OMN-10005072-X (Lot serial: DSAT00105); Model Catalog: OMN-10005072-X (Lot serial: DSAT00111)
  • Descripción del producto
    Omnyx Integrated Digital Pathology System VL120 Scanner IVD
  • Manufacturer
    GENERAL ELECTRIC CANADA (OPERATING AS GE HEALTHCARE)

Manufacturer

GENERAL ELECTRIC CANADA (OPERATING AS GE HEALTHCARE)