ePM Series Patient Monitor. Patient Monitor Series: ePM 10M/ePM 12M/ePM 12MA/ ePM 15M/ePM…
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