Derived label

Device software or design

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.

reason.device_software_design

v1.0.0

Assignment summary

Mode key: device_software_design
Evidence excerpt: defect in software
Rule explanation: Device recall wording explicitly identifies a software, firmware, programming, cybersecurity, or design defect and its failure or consequence.
Firm: Mobius Medical Systems, LP