Lower riskMedical device recall · FDA · Published February 22, 2021
Mindray BeneVision DMS 1.1.1.1: Device may freeze, stop monitoring patients
Mindray BeneVision Distributed Monitoring System (DMS) with specific software versions may freeze, causing patients to lose monitoring data. Affected units include models 115-051209-00 and 115-034414-00/115-034413-00 with software versions 03.04.00 through 04.04.01.
BeneVision DMS may intermittently freeze and require a manual reboot after which normal operation resumes. If a freeze occur, patients monitored on a telemetry transmitter will no longer communicate data to the BeneVision DMS
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Contact the company
📍Recalling firmMindray DS USA, Inc. dba Mindray North America800 Macarthur Blvd · Mahwah, NJ 07430-2001
✎ GovInfoNow plain-language explainer
Mindray BeneVision Distributed Monitoring System (DMS) units with specific software versions may freeze, causing patients to lose monitoring data. This affects certain models and serial numbers listed in the recall. Read more at govinfonow.com/recall/63255-mindray-benevision-dms-1-1-1-1-device-may-freeze.
“Mindray BeneVision DMS 1.1.1.1: Device may freeze, stop monitoring patients.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/63255-mindray-benevision-dms-1-1-1-1-device-may-freeze. Based on FDA recall #Z-1254-2021 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1254-2021%22&limit=1).
The FDA announced on Feb. 22, 2021, that Mindray DS USA Inc. dba Mindray North America is recalling its BeneVision Distributed Monitoring System due to a hazard where the device may intermittently freeze and stop communicating patient data. The recall affects 1,938 systems distributed nationwide and in Canada.
How to tell if you have it
Brand: Mindray
Product: BeneVision Distributed Monitoring System (DMS)
Part numbers: p/n 115-051209-00, p/n 115-034414-00, and p/n 115-034413-00
The BeneVision DMS may intermittently freeze and require a manual reboot after which normal operation resumes. If a freeze occurs, patients monitored on a telemetry transmitter will no longer communicate data to the BeneVision DMS.
Context
GovInfoNow's records show Mindray DS USA Inc. dba Mindray North America has 13 other recalls on record since July 14, 2017. Other recent recalls of similar products include Mindray BeneVision Distributed Monitoring: Audio Failure Risk (Nov. 18, 2025), Mindray Isoflurane V90 Vaporizer Recall (Oct. 20, 2025), and Mindray BeneVision N1 Patient Monitor Recall (Aug. 15, 2025). Other recent recalls of similar products include Philips Patient Information Center iX Software Freezes - Recall (July 31, 2026), Philips PIC iX Essentials Software Freezes: Recall for Patient Data Issues (July 31, 2026), and Philips Telemetry Monitor 5500 1.4 GHz Recall: Risk of Device Reset Causing Connection Failure (June 5, 2026).
How to tell if you have this one
Check for model numbers 115-051209-00 or 115-034414-00/115-034413-00 with software versions 03.04.00 through 04.04.01. Affected units have specific serial numbers listed in the recall.
Brand
Mindray
Category
Medical device
Based on the official FDA remedy
What to do — step by step
Check Software Version
Verify the software version on your device; affected units use software versions 03.04.00 through 04.04.01.
Update Software
Update to a newer software version if available to prevent freezing issues.
Where it went and when
Where it was distributed
Distributed nationwide, and outside the U.S.
Nationwide
Not listed
FDA distribution: “Nationwide 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 30 days after the firm started it.
1Firm started the recall
2FDA classified it Class II
3Published in FDA’s Enforcement Report
Dates from the agency record only; steps without a date are left out.
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-1254-2021 (February 22, 2021) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1254-2021 to see it in context.
Plain-language summary written by qwen3:4b on August 19, 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.