Class II — Potential Health Hazard

Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.

Innocor Cardiopulmonary Exercise and Lung Function Testing System Non-invasive diagnostic Recalled by Innovision A/S Due to The purpose of the recall is to replace...

Date: May 13, 2016
Company: Innovision A/S
Status: Terminated
Source: FDA (Device)

What You Should Do

Stop using this product immediately. Do not consume, use, or distribute it.

Return the product to the place of purchase for a full refund. If you have questions, contact Innovision A/S directly.

Affected Products

Innocor Cardiopulmonary Exercise and Lung Function Testing System Non-invasive diagnostic device that measures or calculates a number of hemodynamic and metabolic parameters.

Quantity: 8

Why Was This Recalled?

The purpose of the recall is to replace data transmission cable (USB-cable) connecting the lnnocor device with an external computer. The replacement USB cable will provide galvanic isolation of the lnnocor from the external computer via opto-couplers, as opposed to the grounding protection currently in use. The replacement is intended to prevent risk of electric shock.

Where Was This Sold?

This product was distributed to 1 state: DC

Affected (1 state)Not affected

About Innovision A/S

Innovision A/S has 1 total recall tracked by RecallDetector.

Related Recalls

Data sourced from the FDA (Device). Last updated March 26, 2026. View original report