BEUDAMED
    FDA Recall Terminated

    FemTouch delivery system includes the FemTouch Kit (AC-1007415) and FemTouch" Tip (SPSA-20002590) Provide fractional treatments in gynecology.

    Recall: Z-0301-2017 · Initiated September 25, 2016

    Recall

    Recall Number
    Z-0301-2017
    Event Number
    75384
    Firm
    Lumenis Limited 13 Hayetzira St., Yokneam Ind. Park Yokneam Israel
    FEI Number
    3004135191
    Product Code
    GEX
    Status
    Terminated
    Root Cause
    Software Manufacturing/Software Deployment
    Initiated
    September 25, 2016
    Posted
    October 23, 2016
    Terminated
    April 11, 2017

    Description

    FemTouch delivery system includes the FemTouch Kit (AC-1007415) and FemTouch" Tip (SPSA-20002590) Provide fractional treatments in gynecology.

    Reason

    The cleaning instructions provided in FemTouch Operator's Manual might be ineffective for a fully assembled device and may lead to a potential for cross-contamination.

    Action

    On 9/25/16 consignees were notified via an Urgent - Field Safety Corrective Action letter with a FemTouch disassembly tool kit as well as FemTouch disassembly instructions. The instructions describe the simple disassembly process to be performed as part of the Pre-cleaning phase and the process for reassembling the device prior to re-use. It is recommended that customers clean and sterilize all of their handpieces according to the pre-cleaning disassembly process before each use. Consignees were asked to complete and return a verification form. Questions about the FSCA, should be directed to the Lumenis field correction administrator, Rafi Barel at [email protected].

    Distribution

    Worldwide Distribution -- USA, Italy, Russian Fed., Australia, United Arab Emirates, Spain, United Kingdom, India, Kuwait, and Belarus.

    Quantity

    69 units