Recall Z-2769-2016— Innovision A/S

Name: FDA recall Z-2769-2016
Creator: U.S. Food and Drug Administration
Published: 2016-05-13

Class II · Terminated

Class II FDA medical device recall by Innovision A/S, initiated 2016-05-13, terminated 2017-02-10. It names one FDA 510(k) clearance: K102047. 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: 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..

Recalling firm: Innovision A/S
Classification: Class II
Status: Terminated
Initiated: 2016-05-13
Terminated: 2017-02-10
Firm location: Glamsbjerg, Denmark

510(k) clearances named in this recall

1 on FDA's record

K102047 — LCI OPTION FOR INNOCORInnovision A/S·cleared 2011-11-01

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.