FDA-Device2026-10-14Class IIIMISBRANDING
Mindray Passport Series Patient Monitor manuals need clarification on alarm functions
What this means
Certain operator's manuals for Mindray Passport Series patient monitors contain unclear or incomplete descriptions of physiological alarm functions. This could make it harder for clinical staff to understand how alarms work. No injuries have been reported.
- Contact Mindray DS USA, Inc. for clarified or updated operator's manuals for your Passport monitor model
- Review your current manual against the affected revision numbers (8/12/12M/17M/V models listed)
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
39,891 units
Manufactured in
800 Macarthur Blvd, N/A, Mahwah, NJ, United States
Products
Passport Series Patient Monitor. Operator's Manuals: 8 / 12 / 12M / 17M / V
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0114-2027More Mindray recalls
- 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
- FDA-Device2026-10-14Mindray Panorama and TMS telemetry monitors need updated operator manuals for alarm functions
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