Events

Rappel de Leica M525 F50 Surgical Microscope with XY-Unit (surgical light microscope)

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-2013-RN-01256-1
  • Classe de risque de l'événement
    Class II
  • Date de mise en oeuvre de l'événement
    2013-11-29
  • 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-2013-RN-01256-1
  • 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
    Leica microsystems has identified that in certain activations of the xy, the system can continue to run laterally to its limit (run-on), but will stop if the surgeon activates any button. run-on of the xy can only occur in the rare situation of rapid consecutive activation on the 45 degrees, 135 degrees, 225 degrees or 315 degrees. in addition, the run-on will stop if any other activation of the xy occurs. the xy run-on is disruptive as the adjustment to the field of view could take up to 24 seconds longer than usual, however there is a low risk to patients.
  • Action
    Leica is providing users with work around instructions to follow as an interim measure. A software upgrade will be implemented as a permanent fix.

Device

Leica M525 F50 Surgical Microscope with XY-Unit (surgical light microscope)
  • Modèle / numéro de série
    Leica M525 F50 Surgical Microscope with XY-Unit (surgical light microscope)Material Number: 10448505Serial numbers: 260213001, 70613002, 80911001, 110613001, 180712001, 30913001Manufactured from 10 May 2010 to 18 November 2013ARTG Number: 137683
  • Manufacturer
    Leica Microsystems Pty Ltd

Manufacturer

Leica Microsystems Pty Ltd