BEUDAMED
    FDA Recall Terminated

    Lumenis brand Lumenis One System with Multi-Spot Nd:YAG, LightSheer and Universal IPL; Manufactured by Lumenis, Ltd, 13 Hayetzira Street, Yokneam Industrial Park, Yokneam, Israel 20692

    Recall: Z-0529-06 · Initiated April 8, 2005

    Recall

    Recall Number
    Z-0529-06
    Event Number
    34556
    Firm
    Lumenis Inc.
    FEI Number
    2914019
    Product Code
    GEX
    Status
    Terminated
    Root Cause
    Other
    Initiated
    April 8, 2005
    Posted
    February 16, 2006
    Terminated
    December 28, 2006
    Address
    2400 Condensa St, Santa Clara, CA, 95051-0901

    Description

    Lumenis brand Lumenis One System with Multi-Spot Nd:YAG, LightSheer and Universal IPL; Manufactured by Lumenis, Ltd, 13 Hayetzira Street, Yokneam Industrial Park, Yokneam, Israel 20692

    Reason

    Software anomaly recorded incorrect filter in patient database and this may lead to patient skin burns.

    Action

    On 4/8/05, the firm initiated the recall and its notification was via letters informing its customers of the corrective action.

    Distribution

    The product was released for distribution to 124 consignees nationwide. One international consignee includes: New Zealand. There were no shipments to U.S. Government facilities or foreign or Canadian distribution.

    Quantity

    142 units