Events

Recall of Certegra Workstation used in conjunction with Medrad Stellant CT 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-01064-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2016-08-11
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2016-RN-01064-1
  • 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
    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
  • Model / Serial
    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
  • Manufacturer Parent Company (2017)
    Bayer AG
  • Source
    DHTGA