Events

Rappel de RPM Respiratory Gating System, version v1.7.5 with 3D Option (Patient respiratory monitoring system used with radiation therapy systems)

Selon Department of Health, Therapeutic Goods Administration, ce/cet/cette rappel concerne un dispositif en/au/aux/à Australia qui a été fabriqué par Varian Medical Systems Australasia 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-00371-1
  • Classe de risque de l'événement
    Class II
  • Date de mise en oeuvre de l'événement
    2013-04-24
  • 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-00371-1
  • 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
    While operating with the 6-dot marker block, this version of rpm gating may produce an inverted respiratory waveform in amplitude and phase-gating sessions. the error may be reproduced if the rpm system is induced to frequently lose and reacquire tracking of the 6-dot marker block during a calibration sequence, a reference session or a single session after tracking has begun.
  • Action
    Varian is providing temporary work around instructions and is implementing a software update to permanently correct the problem.

Device

RPM Respiratory Gating System, version v1.7.5 with 3D Option (Patient respiratory monitoring syst...
  • Modèle / numéro de série
    RPM Respiratory Gating System, version v1.7.5 with 3D Option (Patient respiratory monitoring system used with radiation therapy systems) Product code: H50Multiple serial numbers affectedARTG Number: 117951
  • Manufacturer
    Varian Medical Systems Australasia Pty Ltd

Manufacturer

Varian Medical Systems Australasia Pty Ltd