Derived label
Device software or design
AW-M0001 SONARMED MONITOR. Used in conjunction with SonarMed Acoustic Sensors for airway monitoring.
Assignment summary
- Mode key
- device_software_design
- Evidence excerpt
- Software anomaly resulted in failure
- Rule explanation
- Device recall wording explicitly identifies a software, firmware, programming, cybersecurity, or design defect and its failure or consequence.
- Firm
- SonarMed Inc