Events

Recall of INNOCOR ERGOSPIROMETRY SYSTEM

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

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
    38479
  • Event Risk Class
    III
  • Event Initiated Date
    2016-06-20
  • 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
    The purpose of the recall is to replace data transmission cable (usb-cable) connecting the innocor device with an external computer. the replacement usb cable will provide galvanic isolation of the innocor from the external computer via opto-couplers as opposed to the grounding protection currently in use.

Device

INNOCOR ERGOSPIROMETRY SYSTEM
  • Model / Serial
    Model Catalog: INN00010 (Lot serial: Serial Number: 1543364)
  • Product Description
    INNOCOR ERGOSPIROMETRY SYSTEM
  • Manufacturer
    INNOVISION APS

Manufacturer

INNOVISION APS
  • Manufacturer Address
    GLAMSBJERG
  • Manufacturer Parent Company (2017)
    Innovision Aps
  • Source
    HC