Events

Rappel de Leica M525 F40 Surgical Microscopes

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-00771-1
  • Classe de risque de l'événement
    Class II
  • Date de mise en oeuvre de l'événement
    2017-08-29
  • 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-2017-RN-00771-1
  • 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 the instructions for use (ifu) and warnings are not always followed by users of the leica m525 f40 surgical microscopes, in particular for transportation and positioning in the operating room (or). due to this, additional waning stickers have been introduced for the leica m525 f40, in addition to a quick reference guide for transporting and position in the or which can be attached to the instrument.Using the m525 f40 improperly during transport and positioning can have an adverse effect on the stability of the device. in extreme cases, improper use during transport and positioning can cause tilting of the device. leica microsystems has received two reports where a m525 f40 started tilting due to improper handling.
  • Action
    1. Leica Microsystems is sending warning stickers and “quick reference guides for transport and positioning in the OR”. 2. Users are to arrange the fixation of the warning stickers on the instruments, inform or personnel accordingly and fill out the supplied acknowledge form.

Device

Leica M525 F40 Surgical Microscopes
  • Modèle / numéro de série
    Leica M525 F40 Surgical MicroscopesMaterial Number: 10448096Serial Numbers: 010708001, 010906002, 060505002, 080508001, 100105001, 100608002, 110608001, 180205002, 180410001, 230507001, 231209001, 240609001, 260609001, 290508001, 301106002ARTG Number: 137683
  • Manufacturer
    Leica Microsystems Pty Ltd

Manufacturer

Leica Microsystems Pty Ltd