BEUDAMED
    FDA Enforcement Class II Terminated

    Solero Generator Refurbished US PG, Item No. H78712740000USD0, Catalog No. 12740000USD

    Recall: Z-2436-2021 · Reported September 15, 2021

    Enforcement

    Recall Number
    Z-2436-2021
    Event ID
    88444
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Angiodynamics, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    N/A
    Report Date
    September 15, 2021
    Initiation Date
    July 20, 2021
    Classification Date
    September 8, 2021
    Termination Date
    March 15, 2023
    Address
    603 Queensbury Ave, N/A, Queensbury, NY, 12804-7619, United States

    Description

    Solero Generator Refurbished US PG, Item No. H78712740000USD0, Catalog No. 12740000USD

    Reason

    Specific serial numbers of the Solero MTA Generator require servicing to upgrade the software to help reduce the incidence of Error 0001, which can occur during system start-up.

    Code Info

    Serial Nos. QBY0002546 QBY0002517 QBY0002525 QBY0002562 QBY0002669 QBY0002569 QBY0002382 QBY0002682 QBY0002561 QBY0002567 QBY0002580 QBY0002398 QBY0002379 QBY0002612 QBY0002708 QBY0002527 QBY0002758 QBY0002552

    Distribution

    Domestic distribution Nationwide. Foreign distribution worldwide.

    Quantity

    16 US, 2 OUS