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

Recall number

Z-2769-2016

Recalling firm

Innovision A/S

Product

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

Status

Terminated

Initiated

2016-05-13

Posted

2016-09-08

Terminated

2017-02-10

Reason

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.

Root cause

Device Design

Action

Recall notifications described the issue and actions to be taken by the firm. The notice also stated that replacement costs would be carried by Innovision ApS. Acknowledgment of the notice can be made by contacting service manager Knud Pedersen at kp@innovision.dk or (+45) 65 95 91 00) to schedule the service activity and to answer any questions.

Quantity

8

Distribution

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

Lot, serial or model codes

Ref. INN00400, Serial no. 1551369, 1540362, 1540363, and 1536361.

510(k) numbers

["K102047"]

PMA numbers

not on file

Product code

BZC

Firm FEI

1000334329

Firm city

Glamsbjerg

Firm state

not on file

Firm country

Denmark

Cite as

FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28

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