FDA-Device2026-10-14Class IIIMISBRANDING
Mindray BeneVision N-Series patient monitors need clarified operator manuals for alarm functions
What this means
Certain Mindray BeneVision N1 and N-Series patient monitor operator's manuals contain unclear or incomplete descriptions of how physiological alarm functions work. This may make it harder for clinical staff to understand and properly configure alarm settings.
- Contact Mindray DS USA, Inc. for corrected operator's manuals or clarification documents
- Review your monitor's manual revision number (N1 up to 21.0 or N-Series up to revision 23 are affected)
- Ensure clinical staff receive updated documentation before relying on alarm function descriptions
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
Adults
Illnesses reported
None reported
Sold states
Worldwide - Nationwide and the country of Canada.
Affected count
44,651 units
Manufactured in
800 Macarthur Blvd, N/A, Mahwah, NJ, United States
Products
BeneVision N1 and N-Series Patient Monitor. Patient Monitor: N12/N15/N17/N19/N22.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0110-2027More 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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