BEUDAMED
    FDA Enforcement Class II Terminated

    Liebel-Flarsheim Hydra Vision Urology X-Ray System (DR) Liebel-Flarsheim urology systems facilitate radiologic and/or fluoroscopic procedures requiring a beam of diagnostic quality radiation, primarily for urological applications such as functional x-ray diagnostics, endourology and minimal invasive urology/ surgery.

    Recall: Z-2833-2018 · Reported August 29, 2018

    Enforcement

    Recall Number
    Z-2833-2018
    Event ID
    80174
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    LIEBEL-FLARSHEIM COMPANY LLC
    Voluntary / Mandated
    FDA Mandated
    Initial Notification
    Letter
    Report Date
    August 29, 2018
    Initiation Date
    February 27, 2017
    Classification Date
    August 21, 2018
    Termination Date
    August 16, 2023
    Address
    1034 S Brentwood Blvd, Saint Louis, MO, 63117-1223, United States

    Description

    Liebel-Flarsheim Hydra Vision Urology X-Ray System (DR) Liebel-Flarsheim urology systems facilitate radiologic and/or fluoroscopic procedures requiring a beam of diagnostic quality radiation, primarily for urological applications such as functional x-ray diagnostics, endourology and minimal invasive urology/ surgery.

    Reason

    Software issue. The difference between the display and dosimeter readings In the Child/Pediatric automatic exposure mode is in the range of 52-65%. The display in all other modes deviated by less than 35% from the dosimeter readings.

    Code Info

    Product ID : 750732 SHF-635RF, 750733 SHF-835RF

    Distribution

    US Distribution to: AL, AZ, CA, CT, CO, FL GA, HI, IA, IL, ID, KS, KY, MD, MI, Michigan, MN, NC, NH, NV, NY, OK, OH, PA, SC, TN, TX, VA, WA, WI, and WV,

    Quantity

    313