Events

Retiro De Equipo (Recall) de MRIDIUM MRI INFUSION SYSTEM - PUMP

Según Health Canada (via FOI), este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Canada que fue producido por ROXON MEDI-TECH LTD..

¿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
    38303
  • Clase de Riesgo del Evento
    II
  • Fecha de inicio del evento
    2016-11-18
  • 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
    Change to 1 (one) page on an instruction card set that attaches to the 3860 units. iradimed corp continues to investigate reports of possible fluid free flow and concluded that stretching or improper placement of the iv set during pump set up is the primary cause of these reports. in 2012 iradimed customers received an updated quick reference instruction card which emphasized proper placement of iv set during pump set up. since that time newer customers did not receive this updated quick reference instruction card. though no incidence of injury have occured iradimed is proactively re-issuing this notice to assure the continued safe use of mridium mr infusion pump systems.

Device

MRIDIUM MRI INFUSION SYSTEM - PUMP
  • Modelo / Serial
    Model Catalog: 3860 (Lot serial: > 10 lot # contact Mfg)
  • Descripción del producto
    MRIDIUM MRI Infusion System - Pump;KAMBIN AMD SYSTEM - INSTRUMENT SET
  • Manufacturer
    ROXON MEDI-TECH LTD.

Manufacturer

ROXON MEDI-TECH LTD.