Events

Retiro De Equipo (Recall) de OPTICAL GUIDANCE PLATFORM - SONARRAY MODULE

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
    131453
  • 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 optical guidance platform may not be properly enforcing a 24 hour time limit between optical camera recalibrations. the optical guidance camera has not been evaluated for stability beyond a 24 hour time period and must be recalibrated at least once every 24 hours. this issue is most likely to be found in units upgraded to the 2.6.X software as older versions of the software allowed users to set calibration time outs greater than 24 hours. however all users should check their settings as described. in particular this issue may be found in sonarray systems where users may have increased the calibration time out beyond the factory settings.

Device

OPTICAL GUIDANCE PLATFORM - SONARRAY MODULE
  • Modelo / Serial
    Model Catalog: 97530203A (Lot serial: NZ17010); Model Catalog: 97530203A (Lot serial: HZ19078); Model Catalog: 97530203A (Lot serial: HZ12066)
  • Descripción del producto
    OPTICAL GUIDANCE PLATFORM - SONARRAY MODULE
  • Manufacturer
    VARIAN MEDICAL SYSTEMS INC.

Manufacturer

VARIAN MEDICAL SYSTEMS INC.