Events

Rappel de Device Recall Leica M720 OH5

Selon U.S. Food and Drug Administration, ce/cet/cette rappel concerne un dispositif en/au/aux/à United States 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
    64601
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-2177-2013
  • Date de mise en oeuvre de l'événement
    2012-12-18
  • Date de publication de l'événement
    2013-09-10
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2017-04-24
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=116799
  • Notes / Alertes
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Notes supplémentaires dans les données
    Microscope, surgical, general & plastic surgery - Product Code FSO
  • Cause
    The brake in the z axis and/or brakes in the ab and c axes failed during installation.
  • Action
    The firm, Leica Microsystems, sent an "URGENT MEDICAL DEVICE RECALL" letter dated December 19, 2012 to its customers. The letter described the product, problem and actions to be taken. The customers were instructed to DISCONTINUE USE until your system software is updated and to complete and return the attached Acknowledgement Form via email at LMGRA@leica-microsystems.com or fax to: 847-236-3747 or +41 71 726 32 49 within 10 working days after receipt of field safety notice. Your Leica Mycrosystems will contact you to make the necessary arrangements to complete an upgrade at no charge to the customers. If you have any further questions, contact Regulatory Affairs/Quality Assurance Manager at 847-405-5413 or +41 71 726 32 16.

Device

Device Recall Leica M720 OH5
  • Modèle / numéro de série
    Serial Numbers: OH5-45912,  OH5-46012,  OH5-46112,  OH5-46212,  OH5-46312,  OH5-46412,  OH5-46512,  OH5-46612,  OH5-46712,  OH5-46912,  OH5-47012,  OH5-47112,  OH5-47212,  OH5-47312,  OH5-47412,  OH5-47512,  OH5-47612,  OH5-47812,  OH5-47912,  OH5-48012,  OH5-48112,  OH5-48212,  OH5-48312,  OH5-48312
  • Classification du dispositif
    General and Plastic Surgery Devices
  • Classe de dispositif
    1
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide distribution: USA (Nationwide) including states of: AK, CA, CO, NY, and OR; and countries of: Belarus, China, Hong Kong, India, Indonesia, Italy, Norway, South Africa, Spain, Sweden, Turkey, and Vietnam.
  • Description du dispositif
    Surgical microscope || The device is used to improve the visibility of objects through magnification and illumination and can be applied for observation and documentation and for human veterinary medical treatment.
  • Manufacturer
    Leica Microsystems (Schweiz) Ag

Manufacturer

Leica Microsystems (Schweiz) Ag
  • Adresse du fabricant
    Leica Microsystems (Schweiz) Ag, 201 Max Schmidheiny-Strasse, Heerbrugg Switzerland
  • Société-mère du fabricant (2017)
    Danaher Corporation
  • Source
    USFDA