Reported Sep 14, 2016 · Terminated

Innocor Cardiopulmonary Exercise and Lung Function Testing System Non-invasive diagnostic device that measures or…

Innovision A/S

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: Innovision A/S · Skovvaenget 2 · Glamsbjerg · N/A

Is this the product you have?

  • Innocor Cardiopulmonary Exercise and Lung Function Testing System Non-invasive diagnostic device that measures or calculates a number of hemodynamic and metabolic parameters.
Lot codes and dates
    • Ref. INN00400
    • Serial no. 1551369
    • 1540362
    • 1540363
    • and 1536361
Amount recalled
8

Where it was sold

Why it was 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.

This product could cause temporary or reversible health problems — stop using it.

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA device enforcement) notice

Notice updated Feb 10, 2017 · Data as of Sep 19, 6:02 PM UTC

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