Events

Rappel de Device Recall Mobius 3D

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 Mobius Medical Systems, LP.

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
    77177
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-2100-2017
  • Date de mise en oeuvre de l'événement
    2015-02-23
  • Date de publication de l'événement
    2017-05-16
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2017-07-10
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=155184
  • 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
    Accelerator, linear, medical - Product Code IYE
  • Cause
    Mobius3d version 1.5.0 contained a defect in software code which affects users who perform beam customization, and may lead to a discrepancy in dose calculation between this version of mobius3d (1.5.0) and the prior version (1.4.2), where none should have been expected.
  • Action
    The recalling firm sent an Advisory Notice letter dated February 23, 2015 to customers. The letter identified the affected product, problem and actions to be taken. For questions contact Mobius Medical Systems Customer Support at support@mobiusmed.com.

Device

Device Recall Mobius 3D
  • Modèle / numéro de série
    Version 1.5.0 and 1.5.2 of the Mobius3D software is affected.
  • Classification du dispositif
    Radiology Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide distribution - US Nationwide and the countries of Sweden, Canada, Netherlands, Denmark, Spain, Switzerland, Australia, Austria, Israel, United Kingdom, France
  • Description du dispositif
    Mobius3D || Product Usage: || Mobius3D software is used for quality assurance and treatment plan verification in radiation therapy. It calculates radiation dose three-dimensionally in a representation of a patient or a phantom. The calculation is based on read-in treatment plans that are initially calculated by a treatment planning system, and may additionally be based on external measurements of radiation fields from other sources such as linac delivery log data. Mobius3D is not a treatment planning system. It is only to be used by trained radiation oncology personnel as a quality assurance tool.
  • Manufacturer
    Mobius Medical Systems, LP

Manufacturer

Mobius Medical Systems, LP
  • Adresse du fabricant
    Mobius Medical Systems, LP, 4615 Southwest Fwy Ste 330, Houston TX 77027-7106
  • Société-mère du fabricant (2017)
    Varian Medical Systems Inc
  • Source
    USFDA