Events

Rappel de MRIDIUM MRI INFUSION SYSTEM - PUMP

Selon Health Canada (via FOI), ce/cet/cette rappel concerne un dispositif en/au/aux/à Canada qui a été fabriqué par ROXON MEDI-TECH LTD..

Qu'est-ce que c'est?

Une correction ou un retrait opéré par un fabricant afin de répondre à un problème causé par un dispositif médical. Les rappels surviennent lorsqu'un dispositif médical est défectueux, lorsqu'il pourrait poser un risque pour la santé, ou les deux à la fois.

En savoir plus sur les données ici
  • Type d'événement
    Recall
  • ID de l'événement
    38303
  • Classe de risque de l'événement
    II
  • Date de mise en oeuvre de l'événement
    2016-11-18
  • Pays de l'événement
    Canada
  • Source de l'événement
    HC
  • Notes / Alertes
    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.
  • Notes supplémentaires dans les données
  • Cause
    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
  • Modèle / numéro de série
    Model Catalog: 3860 (Lot serial: > 10 lot # contact Mfg)
  • Description du dispositif
    MRIDIUM MRI Infusion System - Pump;KAMBIN AMD SYSTEM - INSTRUMENT SET
  • Manufacturer
    ROXON MEDI-TECH LTD.

Manufacturer

ROXON MEDI-TECH LTD.