FDA-Device2026-10-14Class IIIMISBRANDING
Mindray Panorama and TMS telemetry monitors need updated operator manuals for alarm functions
What this means
Certain operator's manuals for Mindray Panorama and TMS telemetry monitoring systems contain descriptions of physiological alarm functions that are unclear or incomplete. This could lead to confusion about how alarms work, potentially affecting clinical decision-making.
- Check if your facility has a Panorama Telepack-608 or TMS-6016 monitor (Part Nos. 046-007526-00 or 046-005012-00)
- Contact Mindray DS USA, Inc. for clarified or updated operator manual documentation
- Review alarm function descriptions with your clinical team to ensure everyone understands how to interpret alerts
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
11,831 units
Manufactured in
800 Macarthur Blvd, N/A, Mahwah, NJ, United States
Products
Panorama and Telemetry Monitoring System. Operator's Manuals: TMS-6016/Panorama Telepack-608/TMS60 (TD60).
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0112-2027More 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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