FDA-Device2026-10-14Class IIIMISBRANDING
Mindray ePM Series Patient Monitors need updated operator's manuals for alarm function clarification
What this means
Certain operator's manuals for Mindray ePM Series patient monitors contain unclear or incomplete descriptions of how physiological alarm functions work. This could affect how clinical staff configure and respond to patient alarms. No injuries have been reported.
- Check if your facility uses an ePM 10M, ePM 12M, ePM 12MA, ePM 15M, ePM 10A, or Guardian Plus monitor.
- Contact Mindray DS USA or your equipment supplier to obtain updated operator's manuals with clarified alarm descriptions.
- Review the updated manual and train staff on the corrected alarm settings and functions.
The agency's original wording
Hazard
Certain monitor operator's manuals contain descriptions that may be insufficient or may require clarification regarding selected physiological alarm functions
Intended for
All ages
Illnesses reported
None reported
Sold states
Worldwide - Nationwide and the country of Canada.
Affected count
32,184 units
Manufactured in
800 Macarthur Blvd, N/A, Mahwah, NJ, United States
Products
ePM Series Patient Monitor. Patient Monitor Series: ePM 10M/ePM 12M/ePM 12MA/ ePM 15M/ePM 10A
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0109-2027More Mindray recalls
- FDA-Device2026-10-14Mindray Passport Series Patient Monitor manuals need clarification on alarm functions
- FDA-Device2026-10-14Mindray DS USA T1 Patient Monitor operator's manual needs clarification on alarm functions
- FDA-Device2026-10-14Mindray BeneView T5 and T8 monitor manuals recalled for unclear alarm function descriptions
- FDA-Device2026-10-14Mindray cPM Series Patient Monitor manuals need clarification on alarm functions
- FDA-Device2026-10-14Mindray BeneVision Series Telemetry Monitor manuals recalled for unclear alarm function descriptions
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