BEUDAMED
    FDA Recall Terminated

    HydraVision Digital Imaging System Product ID/Reorder Number: 705559 (65KW)

    Recall: Z-1992-2021 · Initiated March 11, 2021

    Recall

    Recall Number
    Z-1992-2021
    Event Number
    88195
    Firm
    LIEBEL-FLARSHEIM COMPANY LLC
    FEI Number
    3012465398
    Product Code
    MQB
    Status
    Terminated
    Root Cause
    Radiation Control for Health and Safety Act
    Initiated
    March 11, 2021
    Terminated
    September 18, 2024
    Address
    1034 S Brentwood Blvd, Saint Louis, MO, 63117-1223

    Description

    HydraVision Digital Imaging System Product ID/Reorder Number: 705559 (65KW)

    Reason

    Failure to comply with the performance standard for fluoroscopy systems. Per 21 CFR 1020.32(k)(6), the displayed AKR and cumulative air kerma shall not deviate from the actual values by more than 35 percent. The dosage displayed on the generator console and table display (monitor) is higher than the actual delivered dose.

    Action

    The product can be brought into compliance via a software update. The firm plan to have the updated software installed, working with customer schedules, over the course of the next 12 months.

    Distribution

    US Nationwide Distribution and in the country of Canada

    Quantity

    17