Derived label

Device software or design

iPlan RT Dose is a stereotactic radiation treatment planning system that is intended for use in stereotactic, conformal, computer planned, Linac based radiation treatment of cranial, head and neck, and extracranial lesions.

reason.device_software_design

v1.0.0

Assignment summary

Mode key: device_software_design
Evidence excerpt: Software: Potentially incorrect
Rule explanation: Device recall wording explicitly identifies a software, firmware, programming, cybersecurity, or design defect and its failure or consequence.
Firm: Brainlab AG