BeneVision N1 and N-Series Patient Monitor. Patient Monitor: N12/N15/N17/N19/N22.
Official notice from a government agency or its published feed.
Reason: Certain monitor operator's manuals contain descriptions that may be insufficient or may require clarification regarding selected physiological alarm functions
Class IIIThe lowest FDA recall level: unlikely to cause health problems, but it breaks the rules. · Ongoing · Worldwide - Nationwide and the country of Canada.
Hazard: Certain monitor operator's manuals contain descriptions that may be insufficient or may require clarification regarding selected physiological alarm functions
View the FDA enforcement report ↗ ← All reports