BEUDAMED
    FDA Recall Open, Classified

    Covidien Valleylab FT10, FT Series Energy Platform, REF: VLFT10GEN, DLVLFT10GEN, VLFT10GENZD

    Recall: Z-0631-2024 · Initiated November 16, 2023

    Recall

    Recall Number
    Z-0631-2024
    Event Number
    93561
    Firm
    Covidien
    FEI Number
    3026612481
    Product Code
    GEI
    Status
    Open, Classified
    Root Cause
    Software Manufacturing/Software Deployment
    Initiated
    November 16, 2023
    Posted
    January 3, 2024
    Address
    200 Medtronic Dr, Lafayette, CO, 80026

    Description

    Covidien Valleylab FT10, FT Series Energy Platform, REF: VLFT10GEN, DLVLFT10GEN, VLFT10GENZD

    Reason

    Due to software issue, New systems may exhibit an error which may prohibit use of new systems resulting in system being inoperable

    Action

    On November 16 and 20, 2023, Covidien LLC (Medtronic Company) issued a "Urgent: Medical Device Correction" 1. Immediately notify all personnel in all care environments in which the Valleylab" FT10 Energy Platform. 2. Update ValleylabTM FT10 Energy Platform to software version 4.0.4. For additional information see customer communication letter 3. Until the software is updated, the Valleylab" FT10 Energy Platform and LigaSure" devices can continue to be used as instructed in the User Guide and per your facility protocols. 4. Complete the attached Customer Confirmation Form and return it as directed to confirm your receipt and understanding of this information.

    Distribution

    Worldwide distribution - US: Nationwide and surrounding territories.

    Quantity

    47,901 units