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Recall Observatory FDA recall evidence

Derived label

Device software or design

ARIA Radiation Therapy Management (RTM) VERSIONS 13.6, 15.1, 15.5, 15.6, 16.0, 16.1

reason.device_software_design

v1.0.0

Assignment summary

Mode key
device_software_design
Evidence excerpt
Software issue
Rule explanation
Device recall wording explicitly identifies a software, firmware, programming, cybersecurity, or design defect and its failure or consequence.
Firm
Varian Medical Systems Imaging Laboratory GmbH

Field note

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