Innovision A/S recalls Innocor Cardiopulmonary Exercise and Lung Function Testing System Non-invasive diagnostic device that measures or calcu…

Recall date

May 13, 2016

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-2769-2016

FDA classification

Class II

Brand / firm

Innovision A/S

Sold / distributed

Worldwide Distribution -- US, to Massachusetts and Washington, DC; and, the countries of Canada, Germany, and United Kingdom.

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.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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