BEUDAMED
    FDA Recall Terminated

    Hydra Vision DR 60/80 System, Models 700539 and 700540, Liebel-Flarshiem Company. The System is used in radiologic imaging procedures.

    Recall: Z-1753-2013 · Initiated April 25, 2013

    Recall

    Recall Number
    Z-1753-2013
    Event Number
    65176
    Firm
    Leibel-Flarsheim Company LLC
    FEI Number
    1518293
    Product Code
    OWB
    Status
    Terminated
    Root Cause
    Employee error
    Initiated
    April 25, 2013
    Posted
    July 18, 2013
    Terminated
    July 26, 2013
    Address
    2111 E Galbraith Rd, Cincinnati, OH, 45237-1624

    Description

    Hydra Vision DR 60/80 System, Models 700539 and 700540, Liebel-Flarshiem Company. The System is used in radiologic imaging procedures.

    Reason

    A complaint was received in which a hospital physicist indicated the dosage was too high on the HUT system. During the service call the systems Maximum Fluoro Dose was found to be 30 R/min which is three times the Maximum Fluoro Dose limit of 10 R/min.

    Action

    The customers received an "Urgent Device Correction" notification letter on May 12, 2013 explaining the product issue and providing recommended actions. Customers were contacted to set up a service call to test and recalibrate equipment as necessary. Questions were directed to 800-778-7898.

    Distribution

    Nationwide Distribution (US), including the states of TN, KY, CO, KS, CT, HI, and AZ.

    Quantity

    12 units