Events

Recall of Medrad MRXperion MR Injection System

According to Department of Health, Therapeutic Goods Administration, this recall involved a device in Australia that was produced by Imaxeon Pty 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
    RC-2016-RN-00828-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2016-06-21
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2016-RN-00828-1
  • Notes / Alerts
    Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, 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 Australia.
  • Extra notes in the data
  • Reason
    The manufacturer, bayer, has identified that a 4205 error message may occur when mrxperion is installed in a magnetic resonance imaging suite which houses a 3t mr scanner. the occurrence of a 4205 error message is the result of electromagnetic interference when the mrxperion is exposed to radio frequency (rf) energy during certain pulse sequences on 3t scanners. this error message indicates an internal communication error within the device and may require a re-boot of the injection system. if the 4205 error message occurs during a contrast-enhanced mr procedure, users of affected systems may experience the need to repeat the injection and imaging procedure. also, an alternative diagnostic imaging procedure may be required. there have been no patient or user injuries reported as a result of this situation.
  • Action
    Imaxeon is advising users if they encounter a 4205 error message to take the following steps: - With the patient on the table, assess whether to re-boot the MRXperion and proceed with the current scan, proceed with a hand injection if procedure permits, or select an alternate field strength scanner or imaging study. - If the error occurs when the injector is powered on but not in use, then consider re-booting the MRXperion. Imaxeon will be implementing a hardware and software upgrade to permanently correct the issue. This action has been closed-out on 18/05/2017.

Device

Medrad MRXperion MR Injection System
  • Model / Serial
    Medrad MRXperion MR Injection System Catalogue Number: MRXP 200ARTG Number: 156857
  • Manufacturer
    Imaxeon Pty Ltd

Manufacturer

Imaxeon Pty Ltd
  • Manufacturer Parent Company (2017)
    Bayer AG
  • Source
    DHTGA