Derived label
Device software or design
ARTIS pheno, Interventional fluoroscopic x-ray system, Model No. 10849000
Assignment summary
- Mode key
- device_software_design
- Evidence excerpt
- software issues with ARTIS pheno systems with software version VE10B. This may
- Rule explanation
- Device recall wording explicitly identifies a software, firmware, programming, cybersecurity, or design defect and its failure or consequence.