Events

Retiro De Equipo (Recall) de IMPAX

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
    93577
  • Clase de Riesgo del Evento
    II
  • Fecha de inicio del evento
    2015-11-25
  • 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
    When using the extended addendum workflow in impax 6.5.X and above with embedded reporting there is potential for loss of report text when validating addendums. this occurs when all of the conditions listed below happen at the same time: - the dictation or report text is not started as intended at the initial cursor location and - the keyboard arrow keys mouse or speechmike input are used to move the cursor in the addendum before dictating or typing report text and - the "reportstatus" bookmark is used to automatically add the status to the addendum and - with respect to impax 6.5.4 and prior 6.5.X versions the "beginprotect" and "endprotect" bookmarks have not been used to protect the "reportstatus" bookmark. if all of the above conditions are met and the cursor is placed at the "reportstatus" bookmark location when starting to dictate or type report text impax will overwrite the text entered at the "reportstatus" bookmark location with the addendum status when the addendum is validated. as a result some of the text of the addendum is not saved in the validated addendum.

Device

IMPAX
  • Modelo / Serial
    Model Catalog: 6.X (Lot serial: IMPAX 6.5.x and above)
  • Descripción del producto
    IMPAX
  • Manufacturer
    AGFA HEALTHCARE INC.

Manufacturer

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