Events

Retiro De Equipo (Recall) de ARIA RADIATION THERAPY MANAGEMENT

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
    44650
  • Clase de Riesgo del Evento
    II
  • Fecha de inicio del evento
    2015-10-01
  • 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 was identified with the aria for radiation oncology software with a clinical assessment license. admin instructions may not print on drug order prescriptions or be transmitted with e-rx. when the user changes the prescription "type" field after inputting admin instructions in the text box the admin instructions portion of the prescription will not be saved to the database. an e-rx transmitted to the pharmacy will not contain the intended admin instructions. the printed prescription will also not contain the intended admin instructions. this anomaly only occurs for sites that have a clinical assessment license for the aria radiation oncology software / licence set. aria users who do not have a clinical assessment license will not be affected.

Device

ARIA RADIATION THERAPY MANAGEMENT
  • Modelo / Serial
    Model Catalog: 7 9 5 8 5 3 (Lot serial: Contact manufacturer.); Model Catalog: 795853 (Lot serial: >10 serial numbers.); Model Catalog: 7 9 5 8 5 3 (Lot serial: >10 serial numbers.); Model Catalog: 795853 (Lot serial: Contact manufacturer.)
  • Descripción del producto
    Aria Radiation Therapy Management
  • Manufacturer
    VARIAN MEDICAL SYSTEMS INC.

Manufacturer

VARIAN MEDICAL SYSTEMS INC.