Events

Retiro De Equipo (Recall) de HI-ART 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
    49589
  • Clase de Riesgo del Evento
    II
  • Fecha de inicio del evento
    2009-08-17
  • 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
    During radiation treatment the usual data were not visible on the operator station display even though the rad on indicators were active. the treatment was then stopped at around the 4min mark but the system did not mark the treatment as interrupted. when the treatment was re-run the entire treatment was delivered instead of starting at the 4min mark.

Device

HI-ART SYSTEM - KIT-POWER
  • Modelo / Serial
    Model Catalog: 101264 (Lot serial: 110129); Model Catalog: 101264 (Lot serial: 110009); Model Catalog: 101264 (Lot serial: 101212); Model Catalog: 101264 (Lot serial: 10130); Model Catalog: 101264 (Lot serial: 10072); Model Catalog: 101264 (Lot serial: 10014); Model Catalog: 101264 (Lot serial: 10169); Model Catalog: 101264 (Lot serial: 10037)
  • Descripción del producto
    HI-ART SYSTEM
  • Manufacturer
    ACCURAY INCORPORATED

Manufacturer

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