Events

Recall of 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

According to Department of Health, Therapeutic Goods Administration, this recall involved a device in Australia that was produced by Medical Vision Aust Cardiology & Thoracic 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-2015-RN-00715-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2015-08-13
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2015-RN-00715-1
  • 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
    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.
  • Action
    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