Events

Recall of FemTouch delivery system

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Lumenis Limited.

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    75384
  • Event Risk Class
    Class 2
  • Event Number
    Z-0301-2017
  • Event Date Posted
    2016-10-23
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2017-04-11
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=150176
  • Notes / Alerts
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Extra notes in the data
    Powered laser surgical instrument - Product Code GEX
  • 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 Rafi.Barel@lumenis.com.

Device

FemTouch delivery system
  • Model / Serial
    All serial numbers
  • Product Classification
    General and Plastic Surgery Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution -- USA, Italy, Russian Fed., Australia, United Arab Emirates, Spain, United Kingdom, India, Kuwait, and Belarus.
  • Product Description
    FemTouch delivery system includes the FemTouch Kit (AC-1007415) and FemTouch" Tip (SPSA-20002590) || Provide fractional treatments in gynecology.
  • Manufacturer
    Lumenis Limited

Manufacturer

Lumenis Limited
  • Manufacturer Address
    Lumenis Limited, 13 Hayetzira St.,Yokneam Ind. Park, Yokneam Israel
  • Manufacturer Parent Company (2017)
    Laguna Holdco Ltd
  • Source
    USFDA