BEUDAMED
    FDA Enforcement Class II Terminated

    Solero Generator US PG, Item No. H78712740000US0, Catalog No. 12740000US

    Recall: Z-2437-2021 · Reported September 15, 2021

    Enforcement

    Recall Number
    Z-2437-2021
    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 US PG, Item No. H78712740000US0, Catalog No. 12740000US

    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. QBY0002693 QBY0002376 QBY0002765 QBY0002380 QBY0002763 QBY0002662 QBY0002570 QBY0002683 QBY0002551 QBY0002618 QBY0002006 QBY0002293 QBY0002578 QBY0002666 QBY0002378 QBY0002375 QBY0002283 QBY0002539 QBY0002762 QBY0002681 QBY0002690 QBY0002389 QBY0002518 QBY0002670 QBY0002395 QBY0002687 QBY0002613 QBY0002664 QBY0002759 QBY0002780

    Distribution

    Domestic distribution Nationwide. Foreign distribution worldwide.

    Quantity

    26 US, 4 OUS