Events

Rappel de TOPCON – 3D Optical Coherence Tomography 3D OCT-1 MAESTRO machines

Selon Department of Health, Therapeutic Goods Administration, ce/cet/cette rappel concerne un dispositif en/au/aux/à Australia qui a été fabriqué par Device Technologies Australia 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-2015-RN-00517-1
  • Classe de risque de l'événement
    Class II
  • Date de mise en oeuvre de l'événement
    2015-06-19
  • 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-2015-RN-00517-1
  • 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
    In certain usage environments, when the 3d oct-1 is used over a prolonged period of time, dust can penetrate into the optical system and adhere to the surface of the lens. this dust accumulates gradually over time and this can cause a whitish shadow artefact to occur in centre of the image and potentially create a blurry background. if this occurs, the reduced image quality is an obvious anomaly noticed during clinical assessment which cannot be mistaken for patient pathology.
  • Action
    Topcon Corporation will perform a retrofit to block the penetration points to prevent dust from entering into the optical system. In order to do this, Device Technologies will organise the return of affected machines to the manufacturer for the upgrade. A loan unit will be provided for the site whilst their machine is being upgraded. The corrective retro-fit action will be performed in a systematic manner, over a period of time due to the limited number of loan units available. Although affected systems may not exhibit any evidence of this artefact, it is recommended that all units undergo this preventative measure. Customers may continue to use their machine as usual until a loan unit is available for the site.

Device

TOPCON – 3D Optical Coherence Tomography 3D OCT-1 MAESTRO machines
  • Modèle / numéro de série
    TOPCON – 3D Optical Coherence Tomography 3D OCT-1 MAESTRO machines Product code: TOP-470109800ARTG Number: 135436
  • Manufacturer
    Device Technologies Australia Pty Ltd

Manufacturer

Device Technologies Australia Pty Ltd