FDAMay 13, 2016device
Innocor Cardiopulmonary Exercise and Lung Function Testing System Non-invasive diagnostic device that measures or calculates a number of hemodynamic and metabolic parameters.
Official recall recorded by the U.S. Food & Drug Administration.
The 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.
What to do
FDA enforcement status: Terminated
Brands named
innovision a sinnovision
Recall history
No related federal recalls on record for this brand yet.
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