Derived label
Device software or design
iLab Polaris Multi-Modality Guidance System; iLab Ultrasound Imaging System
Assignment summary
- Mode key
- device_software_design
- Evidence excerpt
- software version (disk batch 629774) contained a bug
- Rule explanation
- Device recall wording explicitly identifies a software, firmware, programming, cybersecurity, or design defect and its failure or consequence.