Events

Recall of Volcano S5, S5i, CORE, CORE Mobile Systems with software versions v3.2x, v3.3, v3.4.1 (used to diagnose anatomical defects of the heart or problems associated with myocardial infarction)

According to Department of Health, Therapeutic Goods Administration, this recall involved a device in Australia that was produced by Life Healthcare 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-00602-1
  • Event Risk Class
    Class I
  • Event Initiated Date
    2016-05-10
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2016-RN-00602-1
  • 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
    The manufacturer, volcano corporation has become aware of a system incompatibility issue between the affected systems and hospital network scans. in specific circumstances, a system will encounter unexpected data from the hospital network and the system will need to be manually rebooted. this condition can occur any time, including in the middle of a patient procedure.The system incompatibility issue occurs when hospital staff scan their networks for potential security vulnerabilities and the user is required to manually reboot the system. if this issue occurs during an active procedure, a reboot would result in a delay in the procedure and/or abandonment of the use of ivus and ffr/ifr functionality in the procedure. there have been no reports of injuries associated with this issue.
  • Action
    LifeHealthcare is providing users with work around instructions to follow as an interim measure. A correction is being developed as a permanent correction. This action has been closed-out on 24/05/2017.

Device

Volcano S5, S5i, CORE, CORE Mobile Systems with software versions v3.2x, v3.3, v3.4.1 (used to di...
  • Model / Serial
    Volcano S5, S5i, CORE, CORE Mobile Systems with software versions v3.2x, v3.3, v3.4.1 (used to diagnose anatomical defects of the heart or problems associated with myocardial infarction)ARTG Number: 131371
  • Product Classification
    Cardiovascular Devices
  • Manufacturer
    Life Healthcare Pty Ltd

Manufacturer

Life Healthcare Pty Ltd