Derived label

Device software or design

CORI Starter Kit, Real Intelligence CORI, CORI STARTER KIT - UNIVERSAL.Intended to assist the surgeon in providing software-defined spatial boundaries for orientation and reference information to anatomical structures during orthopedic procedures Product Numbers: (1) ROB10000 CORI Starter Kit (2) ROB10024 Real Intelligence CORI (3) ROB10197 CORI STARTER KIT - UNIVERSAL Note: the three product numbers cover the three different configurations in which the CORI Console is sold

reason.device_software_design

v1.0.0

Assignment summary

Mode key: device_software_design
Evidence excerpt: Software exhibits an increased Marker Registration Error
Rule explanation: Device recall wording explicitly identifies a software, firmware, programming, cybersecurity, or design defect and its failure or consequence.
Firm: Blue Belt Technologies, Inc