Events

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

Selon Department of Health, Therapeutic Goods Administration, ce/cet/cette rappel concerne un dispositif en/au/aux/à Australia qui a été fabriqué par Lumenis Australia Pty Ltd.

Qu'est-ce que c'est?

Une correction ou un retrait opéré par un fabricant afin de répondre à un problème causé par un dispositif médical. Les rappels surviennent lorsqu'un dispositif médical est défectueux, lorsqu'il pourrait poser un risque pour la santé, ou les deux à la fois.

En savoir plus sur les données ici
  • Type d'événement
    Recall
  • ID de l'événement
    RC-2016-RN-01331-1
  • Classe de risque de l'événement
    Class II
  • Date de mise en oeuvre de l'événement
    2016-11-07
  • Pays de l'événement
    Australia
  • Source de l'événement
    DHTGA
  • URL de la source de l'événement
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2016-RN-01331-1
  • Notes / Alertes
    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.
  • Notes supplémentaires dans les données
  • Cause
    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...
  • Modèle / numéro de série
    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