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Recall Observatory FDA recall evidence

Derived label

Device software or design

TomoTherapy Treatment System, Model: Hi-Art, Catalog/Part Number: H-0000-0003, software versions 1.2.0, 1.2.1 and 1.2.2 (Hi-Art¿ 4.2.0, 4.2.1 and 4.2.2). .

reason.device_software_design

v1.0.0

Assignment summary

Mode key
device_software_design
Evidence excerpt
anomalies) with these software
Rule explanation
Device recall wording explicitly identifies a software, firmware, programming, cybersecurity, or design defect and its failure or consequence.
Firm
TomoTherapy Incorporated

Field note

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