Events

Retiro De Equipo (Recall) de RAYSTATION

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

¿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
    41339
  • Clase de Riesgo del Evento
    II
  • Fecha de inicio del evento
    2016-02-23
  • 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
    Issue found with some of the tools used for drawing in and interacting with the patient views and beam's eye views. the issue concerns all tools that are used with the left mouse button held down. these tools can become unsynchronized with the stored data if other commands such as for example a right mouse click are used at the same time as the left mouse button is held down.

Device

RAYSTATION
  • Modelo / Serial
    Model Catalog: 4.0.3 (Lot serial: 4.5); Model Catalog: 4.7 (Lot serial: 4.5); Model Catalog: 4.0.3 (Lot serial: 4.7); Model Catalog: 4.7 (Lot serial: 4.7); Model Catalog: 4.7 (Lot serial: 4.0); Model Catalog: 4.7 (Lot serial: 3.0); Model Catalog: 4.0.3 (Lot serial: 3.5); Model Catalog: 4.7 (Lot serial: 3.5); Model Catalog: 4.0.3 (Lot serial: 4.0); Model Catalog: 4.0.3 (Lot serial: 3.0)
  • Descripción del producto
    RAYSTATION
  • Manufacturer
    RAYSEARCH LABORATORIES AB (PUBL)

Manufacturer

RAYSEARCH LABORATORIES AB (PUBL)