BEUDAMED
    FDA Recall Terminated

    Liebel-Flarsheim Direct Digital Imaging System (DDIS) 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-2834-2018 · Initiated February 27, 2017

    Recall

    Recall Number
    Z-2834-2018
    Event Number
    80174
    Firm
    LIEBEL-FLARSHEIM COMPANY LLC
    FEI Number
    3012465398
    Product Code
    MQB
    Status
    Terminated
    Root Cause
    Radiation Control for Health and Safety Act
    Initiated
    February 27, 2017
    Terminated
    August 16, 2023
    Address
    1034 S Brentwood Blvd, Saint Louis, MO, 63117-1223

    Description

    Liebel-Flarsheim Direct Digital Imaging System (DDIS) 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.

    Action

    The firm, Liebel-Flarsheim, notified its customers by phone on or about 2/27/2017 to inform them of the product, problem and actions to be taken. The firm plans to have these Sedecal software updates implemented over the course of the next 12 months. For additional information, please contact me at 314-376-4788.

    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

    28