Device product
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.
Z-2100-2017
Product summary
- Event
- Event 77177
- Status
- Terminated
- Classification
- Class II
- Quantity
- 270
- Official record key
device-enforcement:Z-2100-2017
Official wording
Reason: 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.
Code information: Version 1.5.0 and 1.5.2 of the Mobius3D software is affected.
Distribution pattern: Worldwide distribution - US Nationwide and the countries of Sweden, Canada, Netherlands, Denmark, Spain, Switzerland, Australia, Austria, Israel, United Kingdom, France
Derived failure modes
-
Device software or design
defect in software