FDA-Device2026-10-14Class IIIMISBRANDING
Mindray DS USA T1 Patient Monitor operator's manual needs clarification on alarm functions
What this means
Certain Mindray T1 Patient Monitor operator's manuals contain descriptions of physiological alarm functions that may be unclear or incomplete. This affects approximately 4,946 units distributed worldwide and in Canada. No injuries have been reported.
- Check if your T1 monitor manual is revision 14.0 or earlier (Part No. 046-006734-00)
- Contact Mindray DS USA or your equipment distributor for clarification on alarm function descriptions
- Review alarm settings and functions with your clinical team to ensure correct understanding
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
4,946 units
Manufactured in
800 Macarthur Blvd, N/A, Mahwah, NJ, United States
Products
T1 Patient Monitor. Operator's Manual: T1 Patient Monitor
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0116-2027More Mindray recalls
- FDA-Device2026-10-14Mindray Passport Series Patient Monitor manuals need 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
Want us to check the next one for you?
We read every CPSC, FDA, USDA, and NHTSA notice and email you a plain-English Sunday brief covering your household — free, no credit card. Or upgrade to as-it-happens alerts for the brands you actually own.