BEUDAMED
    FDA Enforcement Class II Terminated

    V-Twin, Catalog # 6002-800, UDI # 03661540600180 Product Usage: automated chemistry analyzer intended for clinical use

    Recall: Z-0156-2020 · Reported October 23, 2019

    Enforcement

    Recall Number
    Z-0156-2020
    Event ID
    83582
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Vital Scientific N.V.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
    Report Date
    October 23, 2019
    Initiation Date
    January 10, 2012
    Classification Date
    October 16, 2019
    Termination Date
    April 19, 2024
    Address
    24, Kanaalweg, Postbus 100, Dieren, N/A, N/A, Netherlands

    Description

    V-Twin, Catalog # 6002-800, UDI # 03661540600180 Product Usage: automated chemistry analyzer intended for clinical use

    Reason

    The action was initiated due power supply failure. During a power supply failure the instruments malfunctions and no patient results are produced.

    Code Info

    serial numbers: 10-3331; 10-3332; 11-3301; 11-3304 through 11-3306; 11-3308 through 11-3312; 11-3315; 11-3316; 11-3318 through 11-3342; 12-3302.

    Distribution

    US Nationwide in the states of NY, and UT

    Quantity

    39 instruments