FDA-Device2026-10-14Class IIIMISBRANDING
Mindray BeneView T5 and T8 monitor manuals recalled for unclear alarm function descriptions
What this means
Certain operator's manuals for Mindray BeneView Series T5 and T8 patient monitors contain descriptions of physiological alarm functions that may be unclear or incomplete. This could lead to confusion about how alarms work and affect proper device operation.
- If you operate a BeneView T5 or T8 monitor, check your manual revision number (T5 up to revision 17.0 or T8 up to revision 16.0 are affected).
- Contact Mindray DS USA, Inc. for corrected manual documentation or clarification on alarm functions.
- Do not rely solely on the affected manual for critical alarm settings until you receive updated information.
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
133 units
Manufactured in
800 Macarthur Blvd, N/A, Mahwah, NJ, United States
Products
BeneView Series. Operator's Manuals: T5 / T8
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0113-2027More 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 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
- FDA-Device2026-10-14Mindray Panorama and TMS telemetry monitors need updated operator manuals for alarm functions
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