BEUDAMED
    FDA Enforcement Class II Terminated

    Innocor Cardiopulmonary Exercise and Lung Function Testing System Non-invasive diagnostic device that measures or calculates a number of hemodynamic and metabolic parameters.

    Recall: Z-2769-2016 · Reported September 14, 2016

    Enforcement

    Recall Number
    Z-2769-2016
    Event ID
    74649
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Innovision A/S
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    September 14, 2016
    Initiation Date
    May 13, 2016
    Classification Date
    September 8, 2016
    Termination Date
    February 10, 2017
    Address
    Skovvaenget 2, Glamsbjerg, N/A, Denmark

    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

    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.

    Code Info

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

    Distribution

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

    Quantity

    8