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Innovision A/S recalls Innocor Cardiopulmonary Exercise and Lung Function Testing System Non-invasive diagnostic device that measures or c
Recalled September 14, 2016 · FDA recall Z-2769-2016 · Innovision A/S
Hazard
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. · FDA Class II
Units
8
Sold at
Worldwide Distribution -- US, to Massachusetts and Washington, DC; and, the countries of Canada, Germany, and United Kingdom.
Description
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.
Product
Innocor Cardiopulmonary Exercise and Lung Function Testing System Non-invasive diagnostic device that measures or calculates a number of hemodynamic and metabolic parameters.
Manufacturer(s)
Innovision A/S
Made in
Denmark
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →