Events

Retiro De Equipo (Recall) de OPTICAL GUIDANCE PLATFORM - OPTICAL POSITIONING SYSTEM

Según Health Canada (via FOI), este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Canada que fue producido por VARIAN MEDICAL SYSTEMS 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
    71454
  • Clase de Riesgo del Evento
    II
  • Fecha de inicio del evento
    2011-06-28
  • 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 initial date assigned to the plan is the date of the data transfer. this date is updated when any 'new' file is written into the directory. this date may change when performing other functions with a transferred patient file such as saving pre- recorded positions fiducial registration and report or patient settings. therefore exam transferred at time 't' but opened for a quick review in 't'+t may have the later timestamp leading to confusion at the time of exam selection. the risk is a user opens a previous exam for review and then 'saves' the file. they then go to open today's exam however they select the most recent exam (the one they just opened reviewed and saved) thinking it is treatment plan for the day when it is not.

Device

OPTICAL GUIDANCE PLATFORM - OPTICAL POSITIONING SYSTEM
  • Modelo / Serial
    Model Catalog: 97525005A (Lot serial: HZ12066); Model Catalog: 97525005A (Lot serial: HZ17010); Model Catalog: 97525005A (Lot serial: HZ19078)
  • Descripción del producto
    OPTICAL GUIDANCE PLATFORM - OPTICAL POSITIONING SYSTEM
  • Manufacturer
    VARIAN MEDICAL SYSTEMS INC.

Manufacturer

VARIAN MEDICAL SYSTEMS INC.