Derived label
Device software or design
Early Bird Bleed Monitoring System Introducer Sheath Set, REF: FG001-01 (6F), FG001-02 (8F)
Assignment summary
- Mode key
- device_software_design
- Evidence excerpt
- design error
- Rule explanation
- Device recall wording explicitly identifies a software, firmware, programming, cybersecurity, or design defect and its failure or consequence.
- Firm
- Saranas, Inc.