Events

Recall of MRIDIUM MRI INFUSION SYSTEM - PUMP

According to Health Canada (via FOI), this recall involved a device in Canada that was produced by ROXON MEDI-TECH LTD..

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    38303
  • Event Risk Class
    II
  • Event Initiated Date
    2016-11-18
  • Event Country
    Canada
  • Event Source
    HC
  • Notes / Alerts
    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.
  • Extra notes in the data
  • Reason
    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
  • Model / Serial
    Model Catalog: 3860 (Lot serial: > 10 lot # contact Mfg)
  • Product Description
    MRIDIUM MRI Infusion System - Pump;KAMBIN AMD SYSTEM - INSTRUMENT SET
  • Manufacturer
    ROXON MEDI-TECH LTD.

Manufacturer

ROXON MEDI-TECH LTD.