BEUDAMED
    FDA Recall Terminated

    Camera Head OTV-S7H-1D-L08E and Camera Head OTV-S7H-1D-F08E (designed to be used with Olympus endoscopic equipment)

    Recall: Z-2642-2010 · Initiated August 20, 2010

    Recall

    Recall Number
    Z-2642-2010
    Event Number
    56593
    Firm
    Olympus America Inc.
    FEI Number
    2429304
    Product Code
    GCJ
    Status
    Terminated
    Root Cause
    Labeling mix-ups
    Initiated
    August 20, 2010
    Posted
    October 1, 2010
    Terminated
    September 27, 2012
    Address
    3500 Corporate Pkwy. P.O. Box 610, Center Valley, PA, 18034-0610

    Description

    Camera Head OTV-S7H-1D-L08E and Camera Head OTV-S7H-1D-F08E (designed to be used with Olympus endoscopic equipment)

    Reason

    Mislabeled. Endoscopic body-type camera heads labeled as cardiac-type.

    Action

    Asked consignees to return camera heads to correct the labeling.

    Distribution

    nationwide; camera heads were serviced and returned to consignees in March 2003 - September 2007 timeframe

    Quantity

    217 camera heads