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Lower risk Medical device recall · FDA · Published August 31, 2026

Mindray ePM Patient Monitors: Insufficient Alarm Manual Descriptions

Mindray recalls ePM 10M/12M/12MA/15M/10A patient monitors with outdated operator manuals that may not cover all physiological alarm functions properly.

Plain-English summary generated from official FDA data by GovInfoNow · Published by Carlos Caban · How we make summaries

🇺🇸 FDA recall #Z-0109-2027Medical deviceMindray ›
✎ GovInfoNow plain-language explainer

Mindray is recalling ePM Series patient monitors because their operator's manuals might not adequately describe certain physiological alarm functions. This could lead to confusion about when alarms should activate, potentially affecting patient safety during medical monitoring. Read more at govinfonow.com/recall/1629449-mindray-ds-usa-inc-recalls-epm-series-patient-monitor-patient.

Source Summary by GovInfoNow · govinfonow.com/recall/1629449-mindray-ds-usa-inc-recalls-epm-series-patient-monitor-patient · Updated October 21, 2026 · FDA enforcement record: FDA #Z-0109-2027

Cite this page

“Mindray ePM Patient Monitors: Insufficient Alarm Manual Descriptions.” GovInfoNow, updated October 21, 2026. https://govinfonow.com/recall/1629449-mindray-ds-usa-inc-recalls-epm-series-patient-monitor-patient. Based on FDA recall #Z-0109-2027 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0109-2027%22&limit=1).

Mindray DS USA, Inc. recalled ePM Series Patient Monitors due to insufficient operator manual descriptions for physiological alarm functions, according to the FDA on Aug. 31, 2026.

How to tell if you have it

  • Brand: Mindray
  • Product: ePM Series Patient Monitor (ePM 10M/ePM 12M/ePM 12MA/ ePM 15M/ePM 10A)
  • Part No. 046-026408-00 (Guardian Plus Operator's Manual up to rev 4.0)
  • Part No. 046-019796-00 (ePM 10A Operator's Manual up to rev 12.0)
  • Part No. 046-019797-00 (ePM 12MA Operator's Manual up to rev 13.0)
  • Part No. 046-019798-00 (ePM 10M, ePM 12M Operator's Manual up to rev 13.0)
  • Part No. 046-028915-00 (ePM 15M Operator's Manual up to rev 3.0)

The hazard

Certain monitor operator's manuals contain descriptions that may be insufficient or may require clarification regarding selected physiological alarm functions.

Context

GovInfoNow's records show other recent recalls of similar products include Philips IntelliVue MX40: Patient Monitor May Not Alarm (2025-10-31), Philips IntelliVue MX800 Patient Monitor Recall: No Alarms May Cause Missed Alerts (2025-10-31) and Philips IntelliVue MX550 Patient Monitor Recall: No Alarms May Cause Missed Alerts (2025-10-31).

How to tell if you have this one

Check if your patient monitor has a model number starting with ePM 10M, ePM 12M, ePM 12MA, ePM 15M, or ePM 10A. Look for operator's manuals with revision numbers up to 4.0, 12.0, 13.0, or 13.0 for the respective models.

  • Brand
    Mindray
  • Category
    Medical device
FDA recall event · 8 products

All 8 products in this recall

FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.

  • Classification
    Class III
  • Status
    Ongoing
  • Distribution
    Worldwide - Nationwide and the country of Canada.
Recall numberProduct, codes & lotsQuantity
Z-0109-2027ePM Series Patient Monitor. Patient Monitor Series: ePM 10M/ePM 12M/ePM 12MA/ ePM 15M/ePM 10A; Part numbers of ePM Series Patient Monitors Operator's Manuals: 1. Guardian Plus Operator's Manual (OEM, MDPro) up to and including revision 4.0; Part No. 046-026408-00 2. ePM 10A Operator's Manual up to and including revision 12.0; Part No. 046-019796-00 3. ePM 12MA Operator's Manual up to and including revision 13.0; Part No. 046-019797-00 4. ePM 10M, ePM 12M Operator's Manual up to and including revision 13.0; Part No. 046-019798-00 5. ePM 15M Operator's Manual up to and including revision 3.0; Part No. 046-028915-0032,184 units
Z-0110-2027BeneVision N1 and N-Series Patient Monitor. Patient Monitor: N12/N15/N17/N19/N22.; Part numbers of BeneVision N1 and N-Series Patient Monitors Operator's Manuals: 1. BeneVision N1 Operator's Manual up to and including revision 21.0; Part No. 046-011405-00. 2. BeneVision N-Series Operator's Manual up to and including revision 23; Part No. 046-011259-0.44,651 units
Z-0111-2027BeneVision Series Telemetry Monitor. Operator's Manuals: TM70/TM80; Part numbers of BeneVision Series Telemetry Monitor Operator's Manuals: 1. BeneVision TMS60 (TD60)/TM80 (no alarms) Operator's Manual up to and including revision 5.0; Part No. 046-011232-00 2. BeneVision TM70 Telemetry Monitor Operator's Manual up to and including revision 4.0; Part No. 046-019362-00 3. TM80 Telemetry Monitor Operator's Manual up to and including revision 9.0; Part No. 046-012662-00 4. TMS60 Telemetry Monitoring System Operator's Manual up to and including revision 4.0; Part No. 046-007056-0029,737 units
Z-0112-2027Panorama and Telemetry Monitoring System. Operator's Manuals: TMS-6016/Panorama Telepack-608/TMS60 (TD60).; Part Numbers of the Panorama and Telemetry Monitoring System Operator's Manuals: 1. Panorama Telepack-608 Telemetry Monitoring System Operator's Manual up to and including revision 1.0; Part No. 046-007526-00 2. TMS-6016 Operator's Manual up to and including revision 11.0; Part No. 046-005012-0011,831 units
Z-0113-2027BeneView Series. Operator's Manuals: T5 / T8; Part Numbers of the BeneView Series Operator's Manuals: 1. BeneView T5 Operator's Manual up to and including revision 17.0; Part No. 6802-20-66856 2. BeneView T8 Operator's Manual up to and including revision 16.0; Part No. 6800-20-50710133 units
Z-0114-2027Passport Series Patient Monitor. Operator's Manuals: 8 / 12 / 12M / 17M / V; Part Numbers of Passport Series Patient Monitor Operator's Manuals: 1. Passport 8_12 Operator's Manual up to and including revision 13.0; Part No. 046-004417-00 2. Passport 17M 12M Operator's Manual up to and including revision 17.0; Part No. 046-005013-00 3. Passport V Patient Monitors Operating Instructions up to and including revision 10.0; Part No. 0070-00-0704-0239,891 units
Z-0115-2027cPM Series Patient Monitor. Operator's Manual: cPM 8/cPM 12; Part Numbers of the cPM Series Patient Monitor Operator's Manual: 1. cPM 12/cPM 8 Operator's Manual up to and including revision 4.0; Part No. 046-011732-001,699 units
Z-0116-2027T1 Patient Monitor. Operator's Manual: T1 Patient Monitor; T1 Patient Monitor Operator's Manual: 1. T1 Operator's Manual up to and including revision 14.0; Part No. 046-006734-004,946 units
Based on the official FDA remedy

What to do — step by step

  1. Check Operator's Manual Revision

    Identify your monitor's model and the revision number of your operator's manual. Compare it to the listed revision limits in the recall notice.

Where it went and when

Where it was distributed

Distributed nationwide, and outside the U.S.

Alaska: yesAKMaine: yesMEVermont: yesVTNew Hampshire: yesNHWashington: yesWAIdaho: yesIDMontana: yesMTNorth Dakota: yesNDMinnesota: yesMNIllinois: yesILWisconsin: yesWIMichigan: yesMINew York: yesNYRhode Island: yesRIMassachusetts: yesMAOregon: yesORNevada: yesNVWyoming: yesWYSouth Dakota: yesSDIowa: yesIAIndiana: yesINOhio: yesOHPennsylvania: yesPANew Jersey: yesNJConnecticut: yesCTCalifornia: yesCAUtah: yesUTColorado: yesCONebraska: yesNEMissouri: yesMOKentucky: yesKYWest Virginia: yesWVVirginia: yesVAMaryland: yesMDDelaware: yesDEArizona: yesAZNew Mexico: yesNMKansas: yesKSArkansas: yesARTennessee: yesTNNorth Carolina: yesNCSouth Carolina: yesSCDistrict of Columbia: yesDCOklahoma: yesOKLouisiana: yesLAMississippi: yesMSAlabama: yesALGeorgia: yesGAHawaii: yesHITexas: yesTXFlorida: yesFL

FDA distribution: “Worldwide - Nationwide and the country of Canada.” States read from FDA’s own wording; “not listed” means the notice does not name it.

Distributed nationwide, and outside the U.S.

Recall timeline

FDA published this recall 44 days after the firm started it.

1. Firm started the recall: Aug 31, 202612. FDA classified it Class III: Oct 7, 202623. Published in FDA’s Enforcement Report: Oct 14, 202634. Added to GovInfoNow: Oct 21, 202642026
  1. Firm started the recall
  2. FDA classified it Class III
  3. Published in FDA’s Enforcement Report
  4. Added to GovInfoNow

Dates from the agency record only; steps without a date are left out.

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Where this comes from

The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.

  • Official source: FDA Recall #Z-0109-2027 (August 31, 2026) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0109-2027 to see it in context.
  • Plain-language summary written by qwen3:4b on October 21, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
  • GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.
GovInfoNow is an independent guide. We are not FDA or any government agency. Always confirm details with the official recall.Data: CPSC · FDA · NHTSA · USDA