BEUDAMED
    FDA Recall Terminated

    Solero Generator Refurbished PG, Item No. H78712740000D0, Catalog No. 12740000D

    Recall: Z-2438-2021 · Initiated July 20, 2021

    Recall

    Recall Number
    Z-2438-2021
    Event Number
    88444
    Firm
    Angiodynamics, Inc.
    FEI Number
    1319211
    Product Code
    NEY
    Status
    Terminated
    Root Cause
    Software design
    Initiated
    July 20, 2021
    Terminated
    March 15, 2023
    Address
    603 Queensbury Ave, Queensbury, NY, 12804-7619

    Description

    Solero Generator Refurbished PG, Item No. H78712740000D0, Catalog No. 12740000D

    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.

    Action

    On July 20, 2021, the firm initiated the recall by issuing Urgent Voluntary Medical Device Recall letters to affected consignees. Customers were informed of the software upgrade. Customers were asked to return their generators to AngioDynamics for service. The firm's Hardware Service Department will contact you to schedule the upgrade, which may include the shipment of a replacement generator to your facility if needed to be used during the upgrade of your devices. In the interim, while this upgrade is being scheduled, you may continue to use the Solero generator and are instructed to adhere to the following Warning in the current product labeling (User Manual): WARNING: Do not initiate the procedure/anesthesia until the applicator has been connected, primed, and the generator status bar indicates "Ready".

    Distribution

    Domestic distribution Nationwide. Foreign distribution worldwide.

    Quantity

    8 OUS