Innocor Cardiopulmonary Exercise and Lung Function Testing System… — Class II medical device recall Z-2769-2016
Terminated recall by Innovision A/S, reported 2016-09-14, distributed in DC, MA, WA. The purpose of the recall is to replace data transmission cable (USB-cable) connecting the lnnocor device with
| Recall number | Z-2769-2016 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Innovision A/S, Glamsbjerg, Denmark |
| Recall initiated | 2016-05-13 |
| Classified | 2016-09-08 |
| Reported by FDA | 2016-09-14 |
| Terminated | 2017-02-10 |
| Distributed | DC, MA, WA |
| Countries outside the US | CA, DE, GB |
| Quantity | 8 |
| Serial numbers | 1536361, 1540362, 1540363, 1551369 |
| Model numbers | INN00400 |
Product
Innocor Cardiopulmonary Exercise and Lung Function Testing System Non-invasive diagnostic device that measures or calculates a number of hemodynamic and metabolic parameters.
Reason for recall
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-2769-2016. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.