Events

Rappel de Certegra Workstation used in conjunction with Medrad Stellant CT 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-01064-1
  • Classe de risque de l'événement
    Class II
  • Date de mise en oeuvre de l'événement
    2016-08-11
  • 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-01064-1
  • 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
    Medrad has identified that an internal cable connection in the all-in-one computer component of certain certegra workstations used in conjunction with the medrad stellant ct injection system may potentially exhibit thermal events such as smoke, sparks or fire. this is a result of degradation over time of the shielding within the connection. if such an event occurs, a delay of procedure, coughing, nausea, difficulty breathing, or first or second degree burns may occur. there have been no patient or user injuries reported as a result of this situation.
  • Action
    Imaxeon will be arranging for impacted Workstations to be replaced. In the interim, users are advised to take the following actions. 1. While computers are normally warm during use, remain vigilant in checking the back of the Workstation for signs of smoke or other thermal activity while the system is in use. If smoke or other thermal activity is observed, unplug the power cord and discontinue use of your Workstation until it is replaced. 2. Power down the system when you are closing your CT suite for the day or when the CT suite will not be staffed for an extended time and then power it back up prior to your next contrast enhanced CT scan. Interim Instructions for Use with further details will be provided with the customer letter. This action has been closed-out on 22/02/2017.

Device

Certegra Workstation used in conjunction with Medrad Stellant CT Injection System
  • Modèle / numéro de série
    Certegra Workstation used in conjunction with Medrad Stellant CT Injection SystemCatalogue Number: CWKS DISPLAYPart Number: PN 3030896Impacted Workstation Serial Numbers start with KSA051ARTG Number: 170562
  • Manufacturer
    Imaxeon Pty Ltd

Manufacturer

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