Events

Retiro De Equipo (Recall) de PRECISION 500D SYSTEM

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
    41615
  • Clase de Riesgo del Evento
    III
  • Fecha de inicio del evento
    2015-06-16
  • 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 sfd/idd safety mechanism installed on the system may not engage properly at the lower range of sfd/idd travel. this mechanism is installed to hold and prevent the sfd/idd from falling due to a counterweight cable failure. the lower range of travel is 1.1" (28mm) from the lowest point of normal sfd/idd vertical compression.A fall of the sfd/idd could result in an injury to a patient or operator. there have been no reported injuries as a result of this issue.

Device

PRECISION 500D SYSTEM
  • Modelo / Serial
    Model Catalog: 2403791 (Lot serial: > 10 lot numbers contact mfg); Model Catalog: 2403791-3 (Lot serial: > 10 lot numbers contact mfg); Model Catalog: 2258627 (Lot serial: > 10 lot numbers contact mfg)
  • Descripción del producto
    PRECISION 500D SYSTEM
  • Manufacturer
    GENERAL ELECTRIC CANADA (OPERATING AS GE HEALTHCARE)

Manufacturer

GENERAL ELECTRIC CANADA (OPERATING AS GE HEALTHCARE)