Derived label
Device software or design
Triton Canister Software Catalog Number: GAUS-2. Intended adjunct in the estimation of blood loss.
Assignment summary
- Mode key
- device_software_design
- Evidence excerpt
- Software, Insert & Scanning Label may cause the Triton Canister System to output inaccurate blood loss estimates can
- Rule explanation
- Device recall wording explicitly identifies a software, firmware, programming, cybersecurity, or design defect and its failure or consequence.