Events

Rappel de M320 Microscope Systems Article

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-2018-RN-00652-1
  • Classe de risque de l'événement
    Class II
  • Date de mise en oeuvre de l'événement
    2018-06-05
  • 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-2018-RN-00652-1
  • 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
    Internationally, three complaints were reported involving mechanical part failures for the leica m320 microscope system. these specific systems had failures with the screws that hold the gas spring fixation bracket in place . due to this failure, the gas spring, which is fixed to the upper part of the parallelogram, cannot hold up the weight of the optics carrier. this may potentially cause the m320 optics carrier to drop to the lower mechanical end stop.This failure was identical in all three complaints and has been linked to an identified batch of screws, used in the manufacture of the gas spring fixation bracket. these screws have been determined to be non-conforming. in the event that this observed defect were to occur, the m320 optics carrier may unintentionally drop into the surgical field, risking contact with the patient.
  • Action
    Leica is advising they will contact affected users to arrange replacement of the mechanical parts of the parallelogram for all M320 microscopes manufactured with screws from the nonconforming batch.

Device

M320 Microscope Systems Article
  • Modèle / numéro de série
    M320 Microscope Systems Article/Catalogue Numbers: 10448419, 10448420, 10448485 and 10448486 Manufactured between 18 May 2014 and 21 January 2015.ARTG: 137683LEICA MICROSYSTEMS - Microscope, surgical,
  • Manufacturer
    Leica Microsystems Pty Ltd

Manufacturer

Leica Microsystems Pty Ltd