Derived label
Device software or design
Baxter SIGMA Spectrum Infusion Pump with Master Drug Library, Model #/Product Code 35700BAX2
Assignment summary
- Mode key
- device_software_design
- Evidence excerpt
- Software V8.00.02 contains an anomaly
- Rule explanation
- Device recall wording explicitly identifies a software, firmware, programming, cybersecurity, or design defect and its failure or consequence.