BEUDAMED
    FDA Recall Terminated

    Skytron Infinity Series surgical light with triple lightheads, 4 bulbs in each of 3 - 22' diameter lightheads, Manufactured by Dai-ichi Shomei Co., Ltd., Made in Japan; Models IF545454 and IF545454EL.

    Recall: Z-0528-2007 · Initiated January 8, 2007

    Recall

    Recall Number
    Z-0528-2007
    Event Number
    37120
    Firm
    Skytron, Div. The KMW Group, Inc
    FEI Number
    1825014
    Product Code
    FTD
    Status
    Terminated
    Root Cause
    Other
    Initiated
    January 8, 2007
    Posted
    February 22, 2007
    Terminated
    November 18, 2009
    Address
    5000 36th St Se, Grand Rapids, MI, 49512-2008

    Description

    Skytron Infinity Series surgical light with triple lightheads, 4 bulbs in each of 3 - 22' diameter lightheads, Manufactured by Dai-ichi Shomei Co., Ltd., Made in Japan; Models IF545454 and IF545454EL.

    Reason

    If the mounting plug is improperly adjusted, the unit could separate, come apart, and fall from the mount.

    Action

    The firm initially notified consignees of this problem on 11/23/1999 and again on 11/01/2002 and most lights have already been corrected. Remaining consignees with lights in need of correction were notified of the problem via letter dated 1/8/07 and instructed to contact the distributor to have their lights inspected and modified.

    Distribution

    Nationwide and Canada.

    Quantity

    5,000 for all models.