Events

Rappel de LEICA PROVEO 8 OPHTHALMIC MICROSCOPE SYSTEM

Selon Health Canada (via FOI), ce/cet/cette rappel concerne un dispositif en/au/aux/à Canada qui a été fabriqué par LEICA MICROSYSTEMS (SCHWEIZ) AG.

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
    102904
  • Classe de risque de l'événement
    III
  • Date de mise en oeuvre de l'événement
    2017-09-12
  • Pays de l'événement
    Canada
  • Source de l'événement
    HC
  • Notes / Alertes
    Canadian data is current through March 2018. All of the data comes from Health Canada, 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 Canada.
  • Notes supplémentaires dans les données
  • Cause
    For the leica ophthalmic surgical microscope platform proveo 8 a series of intermittent issues which negatively influenced customer satisfaction were identified through customer complaints. 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 funtionality of the hdr recording unit. additionally an anomaly in the device software may also lead to the unexpected behavior that when a user releases a handle or foot switch button this may not immediately end the actuated funtionality. this behavior 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.

Device

LEICA PROVEO 8 OPHTHALMIC MICROSCOPE SYSTEM
  • Modèle / numéro de série
    Model Catalog: 10448808 (Lot serial: 011216001); Model Catalog: 10448808 (Lot serial: 041216001); Model Catalog: 10448808 (Lot serial: 230516001)
  • Description du dispositif
    Leica PROVEO 8 Ophthalmic Microscope System
  • Manufacturer
    LEICA MICROSYSTEMS (SCHWEIZ) AG

Manufacturer

LEICA MICROSYSTEMS (SCHWEIZ) AG