FDA-Device2026-10-14Class IIIMISBRANDING
Mindray BeneVision Series Telemetry Monitor manuals recalled for unclear alarm function descriptions
What this means
Certain operator's manuals for Mindray BeneVision Series Telemetry Monitors (models TM70, TM80, and TMS60) contain descriptions of physiological alarm functions that may be unclear or incomplete. This could potentially lead to confusion when setting up or using alarm features on these patient monitoring devices.
- Check if your facility uses a BeneVision TM70, TM80, or TMS60 telemetry monitor
- Review your current operator's manual revision number against the affected part numbers listed
- Contact Mindray DS USA or your equipment representative for clarified documentation or an updated manual
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
29,737 units
Manufactured in
800 Macarthur Blvd, N/A, Mahwah, NJ, United States
Products
BeneVision Series Telemetry Monitor. Operator's Manuals: TM70/TM80
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0111-2027More 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 Panorama and TMS telemetry monitors need updated operator manuals for alarm functions
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