Events

Rappel de Medrad MRXperion MR Injection System

Selon Department of Health, Therapeutic Goods Administration, ce/cet/cette rappel concerne un dispositif en/au/aux/à Australia qui a été fabriqué par Imaxeon Pty 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
    RC-2016-RN-00828-1
  • Classe de risque de l'événement
    Class II
  • Date de mise en oeuvre de l'événement
    2016-06-21
  • Pays de l'événement
    Australia
  • Source de l'événement
    DHTGA
  • URL de la source de l'événement
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2016-RN-00828-1
  • Notes / Alertes
    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.
  • Notes supplémentaires dans les données
  • Cause
    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
  • Modèle / numéro de série
    Medrad MRXperion MR Injection System Catalogue Number: MRXP 200ARTG Number: 156857
  • Manufacturer
    Imaxeon Pty Ltd

Manufacturer

Imaxeon Pty Ltd
  • Société-mère du fabricant (2017)
    Bayer AG
  • Source
    DHTGA