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
  • 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
  • 1 Event

Fabricant

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