Home / Recalls / Innovision A/S / Z-2769-2016

Z-2769-2016 Class II Terminated

Recalled by Innovision A/S — Glamsbjerg

Recall Details

Product Type: Devices
Report Date: September 14, 2016
Initiation Date: May 13, 2016
Termination Date: February 10, 2017
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 8

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.

Distribution Pattern

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

Code Information

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