Events

Rappel de Leica Proveo 8 Ophthalmic Microscope System

Selon Department of Health, Therapeutic Goods Administration, ce/cet/cette rappel concerne un dispositif en/au/aux/à Australia qui a été fabriqué par Leica Microsystems 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-2017-RN-01247-1
  • Classe de risque de l'événement
    Class II
  • Date de mise en oeuvre de l'événement
    2017-10-30
  • 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-2017-RN-01247-1
  • 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 customer complaints, leica has identified a series of intermittent issues with the leica proveo 8 ophthalmic microscope system, manufactured prior to july 2017.The observed issues can lead to unexpected interruptions of the optics carrier focus drive movement, intermittent stops of the x-y coupling movement or sporadic failures in the proper on-screen display functionality of the hor recording unit. additionally, an anomaly in the device software may also lead to the unexpected behaviour that when a user releases a handle or foot switch button this may not immediately end the actuated functionality. this behaviour can only occur in unlikely workflows where a user changes a user profile or a mode change is initiated at the same time as a functional button is activated.None of the observed issues were related to an actual or potential risk of patient or user injury. the system remains balanced and allows manual override of all main user functions at all time.
  • Action
    Leica Microsystems is providing work around instructions for users to follow as an interim measure. A software and hardware upgrade will be implemented as a permanent correction.

Device

Leica Proveo 8 Ophthalmic Microscope System
  • Modèle / numéro de série
    Leica Proveo 8 Ophthalmic Microscope SystemSerial Numbers: 190216001, 060516001, 280916001 and 061216001Material Number: 10448808Manufactured prior to July 2017ARTG Number: 137683 (LEICA MICROSYSTEMS PTY LTD - Microscope, surgical)
  • Manufacturer
    Leica Microsystems Pty Ltd

Manufacturer

Leica Microsystems Pty Ltd