Events

Retiro De Equipo (Recall) de Volcano IVUS Ultrasound Imaging System Volcano s5 and CORE Series Software versions 3.3, 3.4 (with and without iFR Scout technology) and v3.4 software kits

Según Department of Health, Therapeutic Goods Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Australia que fue producido por Medical Vision Aust Cardiology & Thoracic 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-2015-RN-00715-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2015-08-13
  • 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-2015-RN-00715-1
  • 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
    Volcano corp. has discovered a very specific workflow scenario where the aortic pressure (pa) offset used in the ffr/ifr modalities will be lost or reset to 0 mmhg due to a software error. this issue can lead to an inaccurately calculated ffr or ifr value. should this occur, a clinician may rely on an inaccurate value in diagnosing a patient's condition. if the pa was not zeroed through the volcano system as part of the workflow, this software issue has no impact on the ffr / ifr values or on the patient.
  • Acción
    Medical Vision Australia is advising their customers that if zeroing Pa is warranted, as described in the FFR Option Operator's Manual, performance of this product cannot be assured until the software update is provided. A Medical Vision Australia Representative will contact affected hospitals to schedule a correction to the software in the next few weeks. This action has been closed-out on 24/08/2016.

Device

Volcano IVUS Ultrasound Imaging System Volcano s5 and CORE Series Software versions 3.3, 3.4 (wit...

Manufacturer

Medical Vision Aust Cardiology & Thoracic Pty Ltd