Events

Retiro De Equipo (Recall) de DX-M

Según Health Canada (via FOI), este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Canada que fue producido por AGFA HEALTHCARE INC..

¿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
    23009
  • Clase de Riesgo del Evento
    III
  • Fecha de inicio del evento
    2011-12-06
  • 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
    The dx-g or dx-m digitizer may stop during startup or during a cassette scan cycle and occasionally the images can be lost. at the time a reboot was required to get the system running again. no harm has been reported for this issue. the dx-g or dx-m digitizer may lock up during the cassette scan cycle without any further error messages. at the time reboot was required to get the system running again. no images get lost in this scenario. no harm has been reported for this issue. images did not arrive in the foreseen patient folder at the processing station. some of the lost images could be found in emergency folders and some images were lost completely. the emergency folders are not accessible to the user. in most instances there is a delay in diagnosis with potential retakes required.

Device

DX-M
  • Modelo / Serial
    Model Catalog: 1.0 (Lot serial: NIM_2311); Model Catalog: 5NBGQ (Lot serial: NIM_2311)
  • Descripción del producto
    DX-M DIGITIZER SYSTEM
  • Manufacturer
    AGFA HEALTHCARE INC.

Manufacturer

AGFA HEALTHCARE INC.
  • Dirección del fabricante
    MISSISSAUGA
  • Empresa matriz del fabricante (2017)
    Agfa-Gevaert NV
  • Source
    HC