Derived label

Device software or design

Code Alert Advanced 4-Way Care Solution, CA520 System, PN 9600-1600, RF Technologies. This product is used to alert caregivers when a patient at risk for falls is leaving a bed or chair.

reason.device_software_design

v1.0.0

Assignment summary

Mode key: device_software_design
Evidence excerpt: firmware error
Rule explanation: Device recall wording explicitly identifies a software, firmware, programming, cybersecurity, or design defect and its failure or consequence.
Firm: RF Technologies, Inc.