BEUDAMED
    FDA Recall Terminated

    GENOSYL DS; Nitric Oxide Delivery System Combination Product NDA202860

    Recall: Z-1863-2021 · Initiated May 19, 2021

    Recall

    Recall Number
    Z-1863-2021
    Event Number
    87764
    Firm
    Vero Biotech, LLC
    FEI Number
    3014617112
    Product Code
    MRN
    Status
    Terminated
    Root Cause
    Software design
    Initiated
    May 19, 2021
    Posted
    June 23, 2021
    Terminated
    October 12, 2023
    Address
    387 Technology Cir Nw, Ste 125, Atlanta, GA, 30313-2411

    Description

    GENOSYL DS; Nitric Oxide Delivery System Combination Product NDA202860

    Reason

    Reports received of NO measured below desired dose during transition between primary console and backup console since Software Version 2.2.3 was uploaded to consoles in the field.

    Action

    The firm initiated their recall by visit on 04/07/2021. VERO Clinical Educators are going (or have gone) onsite to the hospitals to physically upgrade the software to v2.2.4. The correction of upgrading the software from v2.2.3 to v2.2.4 began on Wednesday April 7, 2021. The software upgrade is expected to be completed by Friday April 23, 2021. For questions contact VERO Biotech at 1-877-337-4118 or visit the VERO Biotech website at https://www.vero-biotech.com/.

    Distribution

    Distributed nationwide to TX, MD, VA, GA, FL, KS, LA, MN, and NC

    Quantity

    465 units