FDA-Device2026-10-14Class IIIMISBRANDING
Mindray cPM Series Patient Monitor manuals need clarification on alarm functions
What this means
Certain operator's manuals for the Mindray cPM 8 and cPM 12 patient monitors contain descriptions of physiological alarm functions that may be unclear or incomplete. This could affect a clinician's ability to properly configure or interpret alarms on the device.
- Check if your facility has a cPM 8 or cPM 12 monitor with an operator's manual (Part No. 046-011732-00, revision 4.0 or earlier).
- Contact Mindray DS USA, Inc. for updated manual documentation or clarification on alarm settings.
- In the meantime, verify alarm configurations directly on the device display or consult Mindray technical support.
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
1,699 units
Manufactured in
800 Macarthur Blvd, N/A, Mahwah, NJ, United States
Products
cPM Series Patient Monitor. Operator's Manual: cPM 8/cPM 12
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0115-2027More 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 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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