BEUDAMED
    FDA Enforcement Class II Terminated

    Viva-E, Catalog # 6002-380, UDI # 03661540600050 Product Usage: automated chemistry analyzer intended for clinical use

    Recall: Z-0155-2020 · Reported October 23, 2019

    Enforcement

    Recall Number
    Z-0155-2020
    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

    Viva-E, Catalog # 6002-380, UDI # 03661540600050 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: 10-4582 till 10-4584; 10-4586 till 10-4594; 11-2309; 11-2320 t through 11-2328; 11-2330 through-2334; 11-2336 through 11-2375; 11-2383; 11-2384; 11-2388; 11-2395; 12-2314; 12-2315; 12-2324 12-2325.

    Distribution

    US Nationwide in the states of NY, and UT

    Quantity

    75 units