Events

Recall of Volcano s5i, CORE, CORE Mobile Systems with software version V3.5

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-2017-RN-01473-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2017-12-12
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2017-RN-01473-1
  • 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 microsoft windows security settings on a small number of impacted systems were incorrectly configured during the manufacturing process. this misconfiguration can lead to a windows security alert dialog being displayed when the system is switched from ivus to the ffr/ifr mode. if the user responds to the dialog by selecting "allow access," the device's network firewall settings will be modified, opening its network ports to potential unexpected communication from the hospital network.
  • Action
    Life Healthcare is arranging a service technician to visit customers to validate affected systems. In the interim, users may follow the workaround instructions provided in the customer letter to bypass changes to the firewall permissions that may impact the system.

Device

Volcano s5i, CORE, CORE Mobile Systems with software version V3.5
  • Model / Serial
    Volcano s5i, CORE, CORE Mobile Systems with software version V3.5 Part Numbers: 80740001, 400-0100.07, and 400-0100.02Manufactured between 23 March 2016 to 18 October 2017ARTG Number: 131371
  • Manufacturer
    Life Healthcare Pty Ltd

Manufacturer

Life Healthcare Pty Ltd