Events

Recall of Lumenis FemTouch Delivery System (used with AcuPulse laser system and AcuScan120 microscanner for gynecological treatments)

According to Department of Health, Therapeutic Goods Administration, this recall involved a device in Australia that was produced by Lumenis Australia Pty Ltd.

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
    RC-2016-RN-01331-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2016-11-07
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2016-RN-01331-1
  • Notes / Alerts
    Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, except for the categories Manufacturer Parent Company and Product Classification.
    The Parent Company and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Australia.
  • Extra notes in the data
  • Reason
    Lumenis have learned that the cleaning instructions provided in femtouch operator’s manual (um-10065340 rev. b) might be ineffective for a fully assembled device and may lead to a potential for cross-contamination. lumenis initiated a re-verification of the cleaning protocol, and the results showed the current protocol as stated in the instructions for use (ifu) were not effective for an assembled handpiece (tip). this issue affects all femtouch hand pieces and kits. lumenis has not received any reports of injury or harm associated with this potential risk.
  • Action
    Lumenis is asking customers to disassemble the FemTouch tip prior to its cleaning process. This will remove cleaning challenges and allow the device to be effectively cleaned and sterilised using the protocol in the labelling, thereby reducing the potential for cross-contamination.

Device

Lumenis FemTouch Delivery System (used with AcuPulse laser system and AcuScan120 microscanner for...
  • Model / Serial
    Lumenis FemTouch Delivery System (used with AcuPulse laser system and AcuScan120 microscanner for gynecological treatments)FemTouch KitModel Number: AC-1007415FemTouch Tip (supplied in FemTouch Kit)Part Number: SPSA-20002590ARTG Number: 204126
  • Manufacturer
    Lumenis Australia Pty Ltd

Manufacturer

Lumenis Australia Pty Ltd