BEUDAMED
    FDA Recall Terminated

    STERIS Harmony LL 500/700 Surgical Light, Vertical Spring-Loaded Arm. Intended for local illumination of the operating and examination area of the patient in treatment rooms.

    Recall: Z-0414-2010 · Initiated September 11, 2009

    Recall

    Recall Number
    Z-0414-2010
    Event Number
    53475
    Firm
    Steris Corp
    FEI Number
    1527821
    Product Code
    FTD
    Status
    Terminated
    Root Cause
    Device Design
    Initiated
    September 11, 2009
    Posted
    November 23, 2009
    Terminated
    March 1, 2012
    Address
    5960 Heisley Rd, Mentor, OH, 44060

    Description

    STERIS Harmony LL 500/700 Surgical Light, Vertical Spring-Loaded Arm. Intended for local illumination of the operating and examination area of the patient in treatment rooms.

    Reason

    Drger Medical AG & Co., KGaA informed STERIS Corporation that they received (4) reported international cases where a welded seam at the joint of the spring-loaded arm of the Drger SOLA 500/700 surgical light broke as a result of a crack that had slowly developed over time. The STERIS Harmony LL 500/700 surgical light is a Private Label version of the Drger SOLA 500/700 surgical light.

    Action

    The firm sent Urgent Product Correction letters, dated Sept. 11, 2009, to their customers. The letter identified the problem and stated that Drager had supplied STERIS the replacement spring arms and that a STERIS Service Technician would perform the replacement. The letter also stated that the correction would be performed at no charge to the customers. According to the letter, customers would be contacted by their STERIS Service Representative to arrange a convenient time for replacement of potentially affected spring arms. In the meantime, the letter states that customers should use their surgical lights in accordance with the guidelines presented in the Operator's Manual. Questions or concerns regarding the letter should be directed to Barbara Rich at 440-392-7318 or your local STERIS account manager.

    Distribution

    Worldwide Distribution -- USA, including the states of AL, AR, CA, CO, CT, FL, GA, HI, IL, IN, KS, LA, MA, MN, MO, MS, NC, NH, NJ, NV, NY, OH, PA, RI, SC, TN, TX, UT, VA, WA, WI & WY and the country of Canada.

    Quantity

    388 units