Events

Retiro De Equipo (Recall) de Certegra Workstation used in conjunction with Medrad Stellant CT Injection System

Según Department of Health, Therapeutic Goods Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Australia que fue producido por Imaxeon Pty Ltd.

¿Qué es esto?

Una corrección al equipo o acción de retiro tomada por el fabricante para abordar un problema con un dispositivo médico. Los retiros (recalls) ocurren cuando un dispositivo médico está defectuoso, cuando puede poner en riesgo la salud, o cuando simultáneamente está defectuoso y puede poner en riesgo la salud.

Más información acerca de la data acá
  • Tipo de evento
    Recall
  • ID del evento
    RC-2016-RN-01064-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2016-08-11
  • País del evento
    Australia
  • Fuente del evento
    DHTGA
  • URL de la fuente del evento
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2016-RN-01064-1
  • Notas / Alertas
    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.
  • Notas adicionales en la data
  • Causa
    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.
  • Acción
    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
  • Modelo / 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
  • Empresa matriz del fabricante (2017)
    Bayer AG
  • Source
    DHTGA