Events

Retiro De Equipo (Recall) de RAPID STRAND RX

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

¿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
    126095
  • Clase de Riesgo del Evento
    II
  • Fecha de inicio del evento
    2011-09-22
  • 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
    First field complaint received 05 may 11 from poole hospital nhs foundation uk. receipt of rsrx product that was observed to measure approximately 16% below the activity stated within the associated i-125 sealed source calibration certificate (0.449 mci). second field complaint received may 18 from san sebastian where the calibration strand was assayed and activity found to deviate from label by 8.3%. two additional complaints were the orders determined to be mixed with poole and san sebastian.

Device

RAPID STRAND RX
  • Modelo / Serial
    Model Catalog: I125RSRX-ROUND (Lot serial: )
  • Descripción del producto
    Rapid Strand Rx pre-loaded brachytherapy kit
  • Manufacturer
    GE HEALTHCARE CANADA INC.

Manufacturer

GE HEALTHCARE CANADA INC.