Events

Rappel de HARMONIC ACE + Shears with Adaptive Tissue Technology

Selon Department of Health, Therapeutic Goods Administration, ce/cet/cette rappel concerne un dispositif en/au/aux/à Australia qui a été fabriqué par Johnson & Johnson Medical 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-2018-RN-00446-1
  • Classe de risque de l'événement
    Class I
  • Date de mise en oeuvre de l'événement
    2018-05-07
  • 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-2018-RN-00446-1
  • 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
    Through post-market surveillance efforts and through an internal investigation, the manufacturer ethicon, have confirmed that some devices contained in these lots may have been assembled with an internal component that may cause continuous or inadvertent activation of the device.To date, ethicon has not received any reports of adverse events associated with this issue.No other lots of the harmonic ace+ devices (other than those listed) and no other harmonic products are affected by this action.
  • Action
    Johnson & Johnson are advising customers to inspect devices in their possession to determine if their facility has affected product. Customers should then follow the instructions provided in the Acknowledgement Form provided with the Customer Letter to arrange return of affected product.

Device

HARMONIC ACE + Shears with Adaptive Tissue Technology
  • Modèle / numéro de série
    HARMONIC ACE + Shears with Adaptive Tissue TechnologyProduct Code: HAR23 and HAR231Lot Numbers: P9125C, P94C8R, P94G1W, P9125C, P9125C, P94C8R, P94G1W, P9125CARTG Number: 118011(Johnson & Johnson Medical - Electrode, electrosurgical, active, ultrasonic/mechanical vibration, single-use)
  • Classification du dispositif
    General and Plastic Surgery Devices
  • Manufacturer
    Johnson & Johnson Medical Pty Ltd

Manufacturer

Johnson & Johnson Medical Pty Ltd