Mindray BeneVision N1 Patient Monitor Recall: Potential for abnormal alarm pause
Mindray recalls BeneVision N1 Patient Monitors with specific part numbers and software versions due to potential for abnormal alarm pause. Affected units may require correction to prevent monitoring errors.
Lower-risk recall
Potential for activation of an abnormal alarm pause.
Contact the company
What happened, in plain English
Mindray is recalling certain BeneVision N1 Patient Monitors that have specific part numbers and software versions. These units may cause an abnormal alarm pause, which could lead to missed patient alerts. If you own one of these models, you should check your serial numbers and software versions. Read more at govinfonow.com/recall/51605-mindray-benevision-n1-patient-monitor-recall-potential-for-abnormal-alarm.
Source Summary by GovInfoNow · govinfonow.com/recall/51605-mindray-benevision-n1-patient-monitor-recall-potential-for-abnormal-alarm · Updated August 18, 2026 · FDA enforcement record: FDA #Z-2622-2025
Cite this page
“Mindray BeneVision N1 Patient Monitor Recall: Potential for abnormal alarm pause.” GovInfoNow, updated August 18, 2026. https://govinfonow.com/recall/51605-mindray-benevision-n1-patient-monitor-recall-potential-for-abnormal-alarm. Based on FDA recall #Z-2622-2025 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2622-2025%22&limit=1).
Why it’s dangerous
The monitor may activate an abnormal alarm pause, which could cause the device to stop alerting about critical patient conditions. This might lead to missed alerts if the alarm is not functioning properly, but it does not cause physical harm directly.
Who’s affected
Healthcare providers and patients using the BeneVision N1 Patient Monitor with specific part numbers and software versions listed in the recall. The risk is low as the hazard is a potential alarm pause rather than a direct safety hazard.
How to tell if you have this one
Check if your BeneVision N1 Patient Monitor has part numbers 6660E-PA00010 through 6660E-PA00021 or software versions 1.04.00.01 through 1.06.01.01. Also, verify your serial numbers against the list provided in the recall.
- Brand
Mindray- Category
Medical device
What to do — step by step
Check Your Device
Verify your BeneVision N1 Patient Monitor's part number and software version against the list provided in the recall to determine if it is affected.
Contact Mindray
If your device is affected, contact Mindray directly for instructions on how to correct the issue.
Where it went and when
Where it was distributed
Distributed nationwide, and outside the U.S.
FDA distribution: “Worldwide - Nationwide distribution 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 47 days after the firm started it.
- Firm started the recall
- FDA classified it Class II
- Published in FDA’s Enforcement Report
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-2622-2025 (August 15, 2025) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-2622-2025 to see it in context.
- Plain-language summary written by qwen3:4b on August 18, 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.