Mindray BeneVision
Medical device recall Z-1254-2021. Published in FDA’s Enforcement Report on Mar 24, 2021.
No Watch here, and no alerts: openFDA asks that its enforcement data “should not be used as a method to collect data to issue alerts to the public, nor should it be used to track the lifecycle of a recall” (openFDA). For FDA’s own recall emails, subscribe at FDA. FDA’s own record is on accessdata.fda.gov.
The short answer
Published in FDA’s Enforcement Report on Mar 24, 2021. Copied from openFDA on Oct 20, 2026.
- Class II FDA’s class
- Ongoing its status, in FDA’s file
- Nationwide FDA’s word for where it went
- 1938 systems how much, in FDA’s words
Every line below is in FDA’s own words, with its source beside it. FDA’s terms are explained in FDA’s own words.
How serious is it, by FDA’s class?
Class II, the middle of FDA’s three classes.
“Products that might cause a temporary health problem, or pose only a slight threat of a serious nature. Example: a drug that is under-strength but that is not used to treat life-threatening situations.”
openFDA, in plain words, its enforcement report fields.
“Class II is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.”
FDA’s rule, 21 CFR 7.3(m)(2), eCFR.
What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.
What’s wrong with it?
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
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Which ones are recalled?
Mindray BeneVision Distributed Monitoring System( DMS) 1. p/n 115-051209-00 2. p/n 115-034414-00 and 115-034413-00 when used with the following software versions: 03.04.00 04.01.00 04.03.00 04.04.00 04.04.01
1938 systems, in FDA’s words.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Codes to check against yours
Serial Numbers: EHT92003259 EHL5A000498 EHL61000561 EHL67000842 EHL67000843 EHM67000809 EHT04004409 EHT04004412 EHT0A004549 EHT94003329 EHT94003338 EHT94003342 EHT96003496 EHT9C003918 EHT9C003920 EHL64000627 EHL64000629 EHL64000622…
Every code shown here, 1,996 characters
Serial Numbers: EHT92003259 EHL5A000498 EHL61000561 EHL67000842 EHL67000843 EHM67000809 EHT04004409 EHT04004412 EHT0A004549 EHT94003329 EHT94003338 EHT94003342 EHT96003496 EHT9C003918 EHT9C003920 EHL64000627 EHL64000629 EHL64000622 EHL65000697 EHL6B001060 EHL6B001063 EHL6B001069 EHM6C001164 EHL74001282 EHM86002739 EHL5B000545 EHL78001536 EHT07004512 EHT8A002987 EHT02004001 EHT87002783 EHT87002784 EHL5A000463 EHT04004422 EHT92003257 EHL65000729 EHM69000971 EHT89002847 EHT89002850 EHT89002860 EHT87002781 EHL75001349 EHM74001293 EHM75001343 EHL74001301 EHL78001509 EHM69000970 EHT0A004556 EHT8A002980 EHL5A000532 EHM67000801 EHT91003190 EHT99003784 EHL73001200 EHL73001205 EHL73001207 EHT94003326 EHL79001585 EHM7B001731 EHL5A000526 EHL5B000543 EHL65000717 EHL65000721 EHT96003499 EHT88002799 EHT94003339 EHT96003503 EHT9C003922 EHL83002385 EHL81002225 EHL83002304 EHL83002310 EHL74001311 EHL83002387 EHL67000845 EHL73001197 EHL73001198 EHL73001199 EHM67000777 EHM68000887 EHT91003180 EHT91003181 EHT96003500 EHL84002434 EHT06004482 EHL68000900 EHT89002851 EHT89002853 EHT89002855 EHT89002861 EHT04004425 EHT04004410 EHL59000404 EHT92003244 EHL59000382 EHL5B000546 EHL5B000547 EHL65000704 EHL69000931 EHL72001179 EHL77001466 EHT8C003065 EHT8C003066 EHT8C003068 EHT07004496 EHT07004505 EHT88002796 EHL77001469 EHT91003182 EHT91003183 EHT96003540 EHT92003245 EHT92003250 EHT92003251 EHL76001382 EHL79001605 EHL6C001118 EHL65000727 EHL74001312 EHM68000895 EHM68000910 EHT97003624 EHT99003779 EHT99003780 EHL83002405 EHT88002786 EHT94003337 EHL76001383 EHL76001386 EHL76001390 EHL76001392 EHL77001481 EHL77001482 EHL77001483 EHL77001484 EHM74001273 EHM74001297 EHM76001377 EHM76001378 EHL5A000490 EHL5A000496 EHT06004490 EHL67000827 EHT8C003052 EHL73001225 EHL73001231 EHM6A001051 EHM6A001053 EHM6C001096 EHM77001488 EHL84002433 EHL81002219 EHL83002297 EHL83002298 EHL73001209 EHM78001517 EHM68000886 EHL68000902 EHL62000584 EHL61000566 EHL7A001641 EHM7A001666 EHL5A000458 EHL5A000534 EHL81002222…
FDA’s list runs to 13,660 characters. The first part is shown; the rest is on FDA’s record.
Copied exactly as FDA lists them: lot and serial numbers, dates and other codes on the product or its label.
Where did it go?
FDA’s words for the “general area of initial distribution”: where the firm first shipped it.
Nationwide Canada
These words name no state.
What FDA means by nationwide
“The term “nationwide” is defined to mean the fifty states or a significant portion. Note that subsequent distribution by the consignees to other parties may not be included.”
openFDA, its enforcement report fields.
What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.
Is it still going on?
Ongoing, in FDA’s file.
“A recall which is currently in progress.”
openFDA, on “On-Going”, its enforcement report fields.
What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.
- The firm began the recall on Feb 22, 2021.
- FDA classified it on Mar 15, 2021.
- FDA’s Enforcement Report published it on Mar 24, 2021.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Who is recalling it?
- Mindray DS USA, Inc. dba Mindray North America, of Mahwah, NJ.
- Who began it, in FDA’s words: Voluntary: Firm initiated.
- How the firm first told its customers: Letter.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
What this record can’t tell you
- Whether your own one is affected: compare the codes, dates and numbers above with yours. When unsure, ask the firm or the store.
- Where it went after the firm’s first shipments. FDA’s words cover the firm’s initial distribution, and, in FDA’s words, “subsequent distribution by the consignees to other parties may not be included.”
- How many have been returned, corrected or destroyed: FDA’s report doesn’t say.
- Whether anyone was hurt or fell ill: the report doesn’t say.
- How current it is: openFDA publishes FDA’s Enforcement Report weekly, after FDA does, and a firm can announce a recall weeks before it appears there. openFDA’s own caution: “This data should not be used as a method to collect data to issue alerts to the public, nor should it be used to track the lifecycle of a recall.”
- FDA’s list of codes runs to 13,660 characters; the first part is shown here, and the rest is on FDA’s record.
- A product with no recall here isn’t safe by that: FDA’s report lists the recalls FDA classified, and when.
Hearth Record wrote these lines; the quotations are FDA’s.
Sources
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U.S. Food and Drug Administration, Device recall enforcement reports.
Released Oct 14, 2026 and checked Oct 20, 2026. Updated weekly. Public domain (CC0 1.0, openFDA). FDA asks that nothing suggest it endorses this site.
Recalls of food, medicines, medical devices, pet food and animal drugs are from the U.S. Food and Drug Administration (FDA). FDA does not endorse Hearth Record. openFDA: “Do not rely on openFDA to make decisions regarding medical care.” Copied on Oct 20, 2026.