Events

Recall of Volcano - Imaging Systems

According to New Zealand Medicines and Medical Devices Safety Authority, this recall involved a device in New Zealand that was produced by Volcano Corporation, Volcarica SRL.

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
    22333
  • Event Initiated Date
    2017-11-30
  • Event Country
    New Zealand
  • Event Source
    NZMMDSA
  • Event Source URL
    https://medsafe.govt.nz/hot/Recalls/RecallSearch.asp
  • Notes / Alerts
    Data from New Zealand is current through July 2018. All of the data comes from the New Zealand Medicines and Medical Devices Safety Authority, 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 New Zealand.
  • Extra notes in the data
    Recalling Organisation: Device Technologies New Zealand, 47 Arrenway Drive, Albany, AUCKLAND 0632
  • 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 to which the device may be connected.
  • Action
    Manufacturer to issue advice regarding use

Device

Volcano - Imaging Systems
  • Model / Serial
    Model: , Affected: Configuration issue that affects some s5i, CORE and CORE Mobile systems with software version v3.5
  • Manufacturer
    Volcano Corporation, Volcarica SRL

Manufacturer

Volcano Corporation, Volcarica SRL
  • Manufacturer Parent Company (2017)
    Philips
  • Source
    NZMMDSA