Events

Retiro De Equipo (Recall) de AW VOLUMESHARE 4 - THORACIC VCAR

Según Health Canada (via FOI), este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Canada que fue producido por GENERAL ELECTRIC CANADA (OPERATING AS GE HEALTHCARE).

¿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
    92249
  • Clase de Riesgo del Evento
    III
  • Fecha de inicio del evento
    2012-04-25
  • 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
    The recall was initiated due to the findings from a ge site-by-site equipment survey of the core software and optional applications installed on advantage workstations and seno advantage workstations. it was found that on 10 closed recalls there existed customer sites where the correction was not applied. this recall is being deployed to administer the appropriate software upgrades.

Device

AW VOLUMESHARE 4 - THORACIC VCAR
  • Modelo / Serial
    Model Catalog: 5339892-X (Lot serial: Contact Manufacturer); Model Catalog: M80501FL/FK (Lot serial: Contact Manufacturer); Model Catalog: 5191348-2 (Lot serial: Contact Manufacturer); Model Catalog: 5341143-X (Lot serial: Contact Manufacturer)
  • Descripción del producto
    AW VOLUMESHARE 4
  • Manufacturer
    GENERAL ELECTRIC CANADA (OPERATING AS GE HEALTHCARE)

Manufacturer

GENERAL ELECTRIC CANADA (OPERATING AS GE HEALTHCARE)