Events

Retiro De Equipo (Recall) de TOMOTHERAPY TREATMENT SYSTEM - KIT POWER

Según Health Canada (via FOI), este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Canada que fue producido por ACCURAY INCORPORATED.

¿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
    64899
  • Clase de Riesgo del Evento
    II
  • Fecha de inicio del evento
    2010-12-28
  • 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
    Tomotherapy has discovered an anomaly during internal testing. if a tomodirect procedure which consists of 2 to 12 beam angles has an unrecoverable interrupt or emergency stop during a short time period between beam angles there is a small possibility that the procedure will indicate a "performed" status rather than "interrupted" on the operator station. if this occurs the user will not be able to generate a completion procedure. tomotherapy's investigation revealed that when an unrecoverable interrupt or emergency stop occurs with <1 second remaining in a tomodirect beam angle the logic in the software code checks if all the triggers (beam pulses) for the current beam angle is fully delivered and marks the procedure as "performed" rather than interrupted as intended. the anomaly is not taking into account if there are any remaining beam angles to be delivered.

Device

TOMOTHERAPY TREATMENT SYSTEM - KIT POWER
  • Modelo / Serial
    Model Catalog: 101264 (Lot serial: S/N: 10333); Model Catalog: 101264 (Lot serial: S/N: 10332)
  • Descripción del producto
    TOMOTHERAPY TREATMENT SYSTEM - KIT POWER
  • Manufacturer
    ACCURAY INCORPORATED

Manufacturer

ACCURAY INCORPORATED
  • Dirección del fabricante
    MADISON
  • Empresa matriz del fabricante (2017)
    Accuray Inc
  • Source
    HC