Derived label
Device software or design
Sight OLO, Automated Hematology Analyzer, Catalog No. OLO-U1
Assignment summary
- Mode key
- device_software_design
- Evidence excerpt
- software version 2.63, 2.63.1, and 2.63.1.1. Due to the issue
- Rule explanation
- Device recall wording explicitly identifies a software, firmware, programming, cybersecurity, or design defect and its failure or consequence.