Derived label
Device software or design
Merge OrthoCase software. The firm name on the label is Merge Healthcare, Hartland, WI.
Assignment summary
- Mode key
- device_software_design
- Evidence excerpt
- software are changing after saving a plan with a measurement result, which may result in
- Rule explanation
- Device recall wording explicitly identifies a software, firmware, programming, cybersecurity, or design defect and its failure or consequence.