Derived label
Device software or design
RKN130003, RHEO KNEE 3 YR WARRANTY, MD, CE, External lower limb prosthetic component
Assignment summary
- Mode key
- device_software_design
- Evidence excerpt
- firmware issues with the prosthetic knee, there is the potential for unintended warnings and device shutdown which could result in
- Rule explanation
- Device recall wording explicitly identifies a software, firmware, programming, cybersecurity, or design defect and its failure or consequence.
- Firm
- Ossur H / F