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. INN00400Serial no. 155136915403621540363and 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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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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