Events

Recall of Volcano s5/s5i 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 Corp.

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
    13556
  • Event Initiated Date
    2012-09-27
  • 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
    Under very specific and remote conditions two software display errors may occur on the 3.2x intravascylar ultrasound (ivus) software when used with digital ivus catheter and the rotational revolution 45 mhz catheter.
  • Action
    Software to be upgraded

Device

Volcano s5/s5i Imaging Systems
  • Model / Serial
    Model: Models s5 & s5i, Affected: Versions 3.2.1 / 3.2.2
  • Manufacturer
    Volcano Corp

Manufacturer

Volcano Corp
  • Manufacturer Parent Company (2017)
    Philips
  • Source
    NZMMDSA