Events

Recall of S5 IMAGING SYSTEM

According to Health Canada (via FOI), this recall involved a device in Canada that was produced by VOLCANO CORPORATION.

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
    15278
  • Event Risk Class
    II
  • Event Initiated Date
    2016-06-08
  • 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
    Volcano corporation is initiating a voluntary field corrective action because an issue has been identified with sofware versions v3.2.X v3.3 and v3.4 that runs on the s5/s5i/core/core mobile systems ("impacted systems"). this voluntary recall only affects impacted systems. volcano corporation has become aware of a system incompatibility issue between impacted systems and hospital network scans.

Device

S5 IMAGING SYSTEM
  • Model / Serial
    Model Catalog: 804200-001 (Lot serial: >10 NUMBERS CONTACT MFG.); Model Catalog: 807300-001 (Lot serial: >10 NUMBERS CONTACT MFG.); Model Catalog: 807400-001 (Lot serial: >10 NUMBERS CONTACT MFG.); Model Catalog: 806300-001 (Lot serial: >10 NUMBERS CONTACT MFG.); Model Catalog: 807400-001-R (Lot serial: >10 NUMBERS CONTACT MFG.)
  • Product Description
    Volcano s5 Series- s5xs5ix/s5iz;CORE Series- CORE Mobile CORE
  • Manufacturer
    VOLCANO CORPORATION

Manufacturer

VOLCANO CORPORATION
  • Manufacturer Address
    RANCHO CORDOVA
  • Manufacturer Parent Company (2017)
    Philips
  • Source
    HC