BEUDAMED
    FDA Recall Terminated

    Lumenis brand Atlas, Corium, Elite, Elite Ultra 532nm Laser Systems; Manufactured before November 4, 2003; Manufactured by Lumenis, Inc., 3959 West 1820 South, Salt Lake City, Utah 84104

    Recall: Z-0545-06 · Initiated February 1, 2006

    Recall

    Recall Number
    Z-0545-06
    Event Number
    34525
    Firm
    Lumenis Inc.
    FEI Number
    2914019
    Product Code
    GEX
    Status
    Terminated
    Root Cause
    Other
    Initiated
    February 1, 2006
    Posted
    March 2, 2006
    Terminated
    December 21, 2006
    Address
    2400 Condensa St, Santa Clara, CA, 95051-0901

    Description

    Lumenis brand Atlas, Corium, Elite, Elite Ultra 532nm Laser Systems; Manufactured before November 4, 2003; Manufactured by Lumenis, Inc., 3959 West 1820 South, Salt Lake City, Utah 84104

    Reason

    The BP/Notch filter may be out of specification and may cause injury to the patient's eye due to high power (energy) delivered by the Laser System during medical procedures.

    Action

    On 7/26/04 and 2/1/06 the firm initiated the recall and its notification was via letters explaining the reason for the recall and requesting the product be returned for correction.

    Distribution

    Nationwide. The product was released for distribution to 1431 consignees worldwide. International consignees include: Australia, Canada, India, Netherlands, Argentina, France, Malaysia, Italy, Brazil, Mexico, China, Colombia, Thailand, Holland, Japan, and Venezuela. There were no shipments to U.S. Government facilities or foreign or Canadian distribution.

    Quantity

    Approx. 1436 units