Derived label
Device software or design
ACUSON SC2000 Ultrasound Systems with software version 3.5 (VA35); ultrasound imaging system.
Assignment summary
- Mode key
- device_software_design
- Evidence excerpt
- Software issues with ACUSON SC2000 ultrasound with software version 3/5 (VA35) - may
- Rule explanation
- Device recall wording explicitly identifies a software, firmware, programming, cybersecurity, or design defect and its failure or consequence.