Events

Recall of VOLCANO CORE MOBILE SYSTEM MEDICAL EQUIPMENT

According to Health Canada (via FOI), this recall involved a device in Canada that was produced by PHILIPS ELECTRONICS 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
    86178
  • Event Risk Class
    II
  • Event Initiated Date
    2017-11-17
  • Event Country
    Canada
  • Event Source
    HC
  • Notes / Alerts
    Canadian data is current through March 2018. All of the data comes from Health Canada, 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 Canada.
  • Extra notes in the data
  • Reason
    Philips volcano is initiating a voluntary correction to address a configuration issue that affects some s5i and core mobile systems with software version v3.5 ("impacted systems"). on certain impacted systems an unexpected microsoft windows security dialog may appear during use and the user's response to the dialog may adversely affect the subsequent operation of the device. 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 is connected. unexpected communication from the hospital network could include normal network security operations e.G. port scanning. if these communications occur during an active ffr/ifr procedure data recording could be affected leading to: -incorrect ffr/ifr measurements -case delay during troubleshooting and/or port scanning -abandonment of use of the system based on our investigation there is only a remote probability that any of these impacts may occur. (see s64 for french translation).

Device

VOLCANO CORE MOBILE SYSTEM MEDICAL EQUIPMENT
  • Model / Serial
    Model Catalog: 400-0100.01 (Lot serial: ALL); Model Catalog: 807400-001 (Lot serial: ALL)
  • Product Description
    VOLCANO CORE MOBILE SYSTEM MEDICAL EQUIPMENT;S5I IMAGING SYSTEM
  • Manufacturer
    PHILIPS ELECTRONICS LTD.

Manufacturer

PHILIPS ELECTRONICS LTD.
  • Manufacturer Address
    MARKHAM
  • Manufacturer Parent Company (2017)
    Philips
  • Source
    HC