Events

Rappel de Leica Ceiling Mounts MSF-1, MS-1F and MC-1F (Used for mounting 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-2013-RN-00935-1
  • Classe de risque de l'événement
    Class II
  • Date de mise en oeuvre de l'événement
    2013-09-06
  • 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-00935-1
  • 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 is notifying their customers of an important safety issue concerning the ceiling supply units csu 80xx/ csu 60xx, manufactured from 1997 - 2003. the ceiling mount supplier encountered an event in which the drive screw in the motor unit, which lifts and lowers the lower lift arm, broke. as a result, the lift arm fell down approximately 60 cm (23.6 inches).
  • Action
    Leica Microsystems is contacting their customers to arrange for the complete inspection of the ceiling mount and is providing customers with additional preventative maintenance protocols.

Device

Leica Ceiling Mounts MSF-1, MS-1F and MC-1F (Used for mounting surgical microscopes)
  • Modèle / numéro de série
    Leica Ceiling Mounts MSF-1, MS-1F and MC-1F (Used for mounting surgical microscopes)Leica Ceiling Mount MSF-1Art. Numbers: 10446781 & 10446782Leica Ceiling Mount MS-1F & MC-1FArt. Numbers: 10446657 & 10446658ARTG Number: 137683
  • Manufacturer
    Leica Microsystems Pty Ltd

Manufacturer

Leica Microsystems Pty Ltd