Events

Retiro De Equipo (Recall) de DISCOVERY NM/CT 670 SYSTEM - NM GANTRY

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
    54873
  • Clase de Riesgo del Evento
    II
  • Fecha de inicio del evento
    2011-12-22
  • 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
    Ge healthcare has recently become aware of an issue associated with the collimator cart and lead cover of the discovery nm/ct 670 and/or discovery nm 630 system that may impact operator safety. they are: 1. the cart locking pin release and cart disengagement could result in the collimator falling down and could lead to operator or service personnel injury. 2. another issue is that the lead cover handle separation could result in plate swing resulting in potential injury to service personnel. please note there are no affected install units for the discovery nm 630.

Device

DISCOVERY NM/CT 670 SYSTEM - NM GANTRY

Manufacturer

GENERAL ELECTRIC CANADA (OPERATING AS GE HEALTHCARE)