BEUDAMED
    FDA Enforcement Class II Terminated

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

    Recall: Z-0301-2017 · Reported November 2, 2016

    Enforcement

    Recall Number
    Z-0301-2017
    Event ID
    75384
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Lumenis Limited
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    November 2, 2016
    Initiation Date
    September 25, 2016
    Classification Date
    October 23, 2016
    Termination Date
    April 11, 2017
    Address
    13 Hayetzira St.,Yokneam Ind. Park, Yokneam, N/A, Israel

    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.

    Code Info

    All serial numbers

    Distribution

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

    Quantity

    69 units