BEUDAMED
    FDA Enforcement Class II Terminated

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

    Recall: Z-1992-2021 · Reported July 14, 2021

    Enforcement

    Recall Number
    Z-1992-2021
    Event ID
    88195
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    LIEBEL-FLARSHEIM COMPANY LLC
    Voluntary / Mandated
    FDA Mandated
    Initial Notification
    Letter
    Report Date
    July 14, 2021
    Initiation Date
    March 11, 2021
    Classification Date
    July 2, 2021
    Termination Date
    September 18, 2024
    Address
    1034 S Brentwood Blvd, Saint Louis, MO, 63117-1223, United States

    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.

    Code Info

    Product ID/Reorder Number: 705559 (65KW), 705560 (80KW) Model/NDC: HUTSHVDIS

    Distribution

    US Nationwide Distribution and in the country of Canada

    Quantity

    17