Z-2769-2016Class II

Innocor Cardiopulmonary Exercise and Lung Function Testing System Non-invasive diagnostic device that...

Name: Z-2769-2016 Innocor Cardiopulmonary Exercise and Lung Function Testing System Non-invasive diagnostic device that...
Creator: Innovision A/S
Published: 2016-05-13
License: https://open.fda.gov/license/

Innovision, Inc. / initiated 2016-05-13 / Terminated / root cause: design

FDA source

Innovision A/S began a recall of Innocor Cardiopulmonary Exercise and Lung Function Testing System Non-invasive diagnostic device that measures or calculates a number of hemodynamic and... on 2016-05-13. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-2769-2016
Classification: Class II
Status: Terminated
Initiated: 2016-05-13
Posted: 2016-09-08
Terminated: 2017-02-10
Recalling firm: Innovision, Inc.
Product: Innocor Cardiopulmonary Exercise and Lung Function Testing System Non-invasive diagnostic device that measures or calculates a number of hemodynamic and metabolic parameters.
Product code: BZC Calculator, Pulmonary Function Data
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.
Root cause tag: design
FDA 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 [email protected] or (+45) 65 95 91 00) to schedule the service activity and to answer any questions.
Quantity in commerce: 8
Distribution: Worldwide Distribution -- US, to Massachusetts and Washington, DC; and, the countries of Canada, Germany, and United Kingdom.
Product codes and lots: Ref. INN00400, Serial no. 1551369, 1540362, 1540363, and 1536361.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2769-2016
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2769-2016	Class II	Terminated	Voluntary: Firm initiated	2016-09-14	2016-09-08

Product code BZC

K102047Class IILci Option for InnocorInnovision A/S / cleared 2011-11-01

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)