BEUDAMED
    FDA Recall Terminated

    Hydradjust IV DR Urological Table Sedecal Generator (p/n 750732 - 64W generator & p/n 750733 80W generator). Mallinckrodt, Inc. Cincinnati, OH 45237. Facilitates digital radiologic and/or fluoroscopic procedures requiring a beam of diagnostic quality radiation and a flat imaging table.

    Recall: Z-1904-2010 · Initiated June 14, 2010

    Recall

    Recall Number
    Z-1904-2010
    Event Number
    55953
    Firm
    Mallinckrodt Inc
    FEI Number
    1518293
    Product Code
    IZO
    Status
    Terminated
    Root Cause
    Process control
    Initiated
    June 14, 2010
    Posted
    June 25, 2010
    Terminated
    February 25, 2012
    Address
    2111 E Galbraith Rd, Cincinnati, OH, 45237-1624

    Description

    Hydradjust IV DR Urological Table Sedecal Generator (p/n 750732 - 64W generator & p/n 750733 80W generator). Mallinckrodt, Inc. Cincinnati, OH 45237. Facilitates digital radiologic and/or fluoroscopic procedures requiring a beam of diagnostic quality radiation and a flat imaging table.

    Reason

    Covidien received complaints of the Sedecal Generator failing and producing smoke at customer sites. The failure modes are located in different parts of the generator and will lead to the generator becoming inoperative.

    Action

    Covidien Issued an "Urgent Device Correction" notification dated June 14, 2010 informing their customers of the potential problem. Consignees were instructed that Field Service Engineers will be in contact arrange a service visit to perform corrections on the affected units. For further information, contact Covidien Product Monitoring at 1-800-778-7898.

    Distribution

    Worldwide Distribution -- United States, Canada and China.

    Quantity

    144 units