BEUDAMED
    FDA Enforcement Class II Terminated

    Lumenis VersaCut+ Tissue Morcellator GA-0007500 The Lumenis VersaCut / VersaCut+ Tissue Morcellator System is intended for use under direct or endoscopic visualization for the morcellation and removal of dissected tissue during pelviscopic, laparoscopic, percutaneous, and open surgical procedures whenever access to the surgical site is limited.

    Recall: Z-2770-2015 · Reported September 23, 2015

    Enforcement

    Recall Number
    Z-2770-2015
    Event ID
    71851
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Lumenis
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    September 23, 2015
    Initiation Date
    July 30, 2015
    Classification Date
    September 16, 2015
    Termination Date
    May 25, 2018
    Address
    13 Hayetzira St.,Yokneam Ind. Park, Yokneam, N/A, Israel

    Description

    Lumenis VersaCut+ Tissue Morcellator GA-0007500 The Lumenis VersaCut / VersaCut+ Tissue Morcellator System is intended for use under direct or endoscopic visualization for the morcellation and removal of dissected tissue during pelviscopic, laparoscopic, percutaneous, and open surgical procedures whenever access to the surgical site is limited.

    Reason

    There is a probability the hand piece may operate inconsistently and unpredictably during the morcellation procedure resulting in damage to non-target tissue.

    Code Info

    GA-0007500 (VersaCut + System with Inverted H/P) and GA-0007600 (VersaCut + System with Regular H/P). Only the hand pieces for the system (SA4769200 inverted HP, SA4768700 regular HP) are affected by this recall.

    Distribution

    Worldwide Distribution - US including CA, PA, MA, FL, and NY, and Internationally to Italy, Germany, Australia, China, Great Britian, United Kingdom, Taiwan, France, Peru, Mexico, Turkey, Spain, and Russia.

    Quantity

    54 devices with 108 hand pieces