Events

Retiro De Equipo (Recall) de ARIA OFFLINE REVIEW SOFTWARE

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
    135800
  • Clase de Riesgo del Evento
    II
  • Fecha de inicio del evento
    2009-06-10
  • 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
    An anomaly exists in the software which leads to a record save fail in the case that a partially treated fraction has zero dose accumulation. if the change to the plan had been to parameters other than dose per fraction treatment to incorrect volume could resultpotentially leading to serious injury.

Device

ARIA OFFLINE REVIEW SOFTWARE
  • Modelo / Serial
    Model Catalog: HIT (Lot serial: contact manufacturer.); Model Catalog: 8.6.07 (Lot serial: contact manufacturer.); Model Catalog: 8.5.11 (Lot serial: contact manufacturer.); Model Catalog: 8.1.15 (Lot serial: contact manufacturer.); Model Catalog: HIT (Lot serial: >10 serial numbers.); Model Catalog: 8.1.15 (Lot serial: >10 serial numbers.); Model Catalog: 8.6.07 (Lot serial: >10 serial numbers.); Model Catalog: 8.5.11 (Lot serial: >10 serial numbers.); Model Catalog: HIT (Lot serial: contact manufacturer); Model Catalog: 8.6.07 (Lot serial: contact manufacturer); Model Catalog: 8.5.11 (Lot serial: contact manufacturer); Model Catalog: 8.1.15 (Lot serial: contact manufacturer)
  • Descripción del producto
    Aria Offline Review Software
  • Manufacturer
    VARIAN MEDICAL SYSTEMS INC.

Manufacturer

VARIAN MEDICAL SYSTEMS INC.