Innocor Cardiopulmonary Exercise and Lung Function Testing System Non-invasive diagnostic device that measures or calculates a number of hemodynamic and metabolic parameters.
FDA Recall Z-2769-2016 · Posted 2016-09-08
Recalling FirmInnovision A/S
Recall StatusTerminated
Product CodeBZC
Date Initiated2016-05-13
Date Terminated2017-02-10
Product Quantity8
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.
Firm 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 [email protected] or (+45) 65 95 91 00) to schedule the service activity and to answer any questions.
Root Cause
Device Design
Distribution Pattern
Worldwide Distribution -- US, to Massachusetts and Washington, DC; and, the countries of Canada, Germany, and United Kingdom.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.