Events

Rappel de LEICA M525 F50 SURGICAL MICROSCOPES

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

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
    27214
  • Classe de risque de l'événement
    III
  • Date de mise en oeuvre de l'événement
    2013-12-04
  • 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
    Leica microsystems (schweiz) ag evaluated data of an internal report showing that it is possible an unspecified behaviour of the optional xy-unit for the leica m525 f50 and leica m525 c50. to date have not received any customer complaints involving a malfunction in the xy unit. by moving the xy-joysticks of the handle or the footswitch diagonally it is possible that the xy-unit will unintentionally proceed in one direction until the end stop is reached. consecutive entries in diagonal direction will contribute to the probability to stipulate this problem. after the xy movement is stopped by end stop or interruption through orthogonal xy-joystick command the xy-unit can be operated normally.

Device

LEICA M525 F50 SURGICAL MICROSCOPES
  • Modèle / numéro de série
    Model Catalog: M525 F50 (Lot serial: 271212001); Model Catalog: M525 F50 (Lot serial: 60312001); Model Catalog: M525 F50 (Lot serial: 110513001); Model Catalog: M525 F50 (Lot serial: 30613001)
  • Description du dispositif
    LEICA M525 F50 SURGICAL MICROSCOPES
  • Manufacturer
    LEICA MICROSYSTEMS CANADA

Manufacturer

LEICA MICROSYSTEMS CANADA