Derived label

Device software or design

Zyno Medical Z800 Large Volume Infusion Pumps -Intended to provide intravenous infusion of parenteral fluids, blood and blood products to a patient under the direction or supervision of physician or other certified health care professional Model: Z-800WF

reason.device_software_design

v1.0.0

Assignment summary

Mode key: device_software_design
Evidence excerpt: software version 5.2.05, the alarm volume may
Rule explanation: Device recall wording explicitly identifies a software, firmware, programming, cybersecurity, or design defect and its failure or consequence.
Firm: Zyno Medical LLC