Innovision A/S: Medical Device Recall in 2016 - (Recall #: Z-2769-2016)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2016.

Data Source: FDA.

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.

Product Classification:

Class II

Date Initiated: May 13, 2016

Date Posted: September 14, 2016

Recall Number: Z-2769-2016

Event ID: 74649

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.

Status: Terminated

Product Quantity: 8

Code Information:

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

Distribution Pattern:

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

Voluntary or Mandated:

Voluntary: Firm initiated