BEUDAMED
    FDA Enforcement Class II 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 · Reported July 24, 2013

    Enforcement

    Recall Number
    Z-1753-2013
    Event ID
    65176
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Leibel-Flarsheim Company LLC
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    July 24, 2013
    Initiation Date
    April 25, 2013
    Classification Date
    July 18, 2013
    Termination Date
    July 26, 2013
    Address
    2111 E Galbraith Rd, N/A, Cincinnati, OH, 45237-1624, United States

    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.

    Code Info

    The following catalog numbers, serial numbers and associated manufacturing dates are affected by this recall: 700539 CI0807H273 August2007; 700539 CI0106H162 January 2006; 700539 CI1010H523 October 2010; 700539 CI0811H567 August 2011; 700539 CI0108H313 January 2008; 700539 CI0309H418 March 2009; 700539 15031229 Apri12003; 700539 14031227 Apri12003; 700539 CI0404H045 January 2005; 700539 CI0504H054 May 2004; 700539 CI1106H208 November 2006; 700539 CI0509H424 May 2009

    Distribution

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

    Quantity

    12 units