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Lower risk Medical device recall · FDA · Published May 17, 2021

Mediana AVSM3 SNF Vital Signs Monitor: Power Failure Risk

Mediana recalls AVSM3 SNF vital signs monitors with serial numbers 460062000002-460062000501 and 460062100033-460062100150 due to potential power failure and unresponsive buttons.

🇺🇸 FDA recall #Z-2096-2021Medical deviceMediana ›
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Contact the company

Recalling firmMediana Co., Ltd.132 Donghwagongdan-Ro, Munmag-Eup · Wonju, Korea (the Republic of)
✎ GovInfoNow plain-language explainer

What happened, in plain English

Mediana is recalling its AVSM3 SNF vital signs monitors because they sometimes fail to power up or have unresponsive buttons. This could lead to inaccurate blood pressure readings or other vital signs monitoring, which is important for patient safety. Read more at govinfonow.com/recall/62537-mediana-avsm3-snf-vital-signs-monitor-power-failure-risk.

Source Summary by GovInfoNow · govinfonow.com/recall/62537-mediana-avsm3-snf-vital-signs-monitor-power-failure-risk · Updated August 19, 2026 · FDA enforcement record: FDA #Z-2096-2021

Cite this page

“Mediana AVSM3 SNF Vital Signs Monitor: Power Failure Risk.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/62537-mediana-avsm3-snf-vital-signs-monitor-power-failure-risk. Based on FDA recall #Z-2096-2021 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2096-2021%22&limit=1).

Why it’s dangerous

The monitors may fail to power up or have unresponsive buttons, which could result in inaccurate vital signs readings. This might affect the ability to monitor critical patient health metrics like blood pressure, oxygen levels, and heart rate.

Who’s affected

Healthcare facilities using Mediana AVSM3 SNF monitors with serial numbers 460062000002 through 460062000501 and 460062100033 through 460062100150 are likely affected. Staff using these monitors for patient vital signs monitoring may be at risk if the device fails to function properly.

How to tell if you have this one

Check the serial number on the monitor, which should be between 460062000002 and 460062000501 or between 460062100033 and 460062100150. The device is intended for use in hospitals and hospital-like facilities.

  • Brand
    Mediana
  • Product
    AVSM3 SNF, Vital Signs Monitor The monitor is intended to be used to monitor noninvasive blood pressure (NIBP)
  • Category
    Medical device
Based on the official FDA remedy

What to do — step by step

  1. Check Monitor Functionality

    Test if the monitor powers up and all buttons respond normally before use.

Where it went and when

Where it was distributed

Distributed in Wisconsin.

Alaska: not listedAKMaine: not listedMEVermont: not listedVTNew Hampshire: not listedNHWashington: not listedWAIdaho: not listedIDMontana: not listedMTNorth Dakota: not listedNDMinnesota: not listedMNIllinois: not listedILWisconsin: yesWIMichigan: not listedMINew York: not listedNYRhode Island: not listedRIMassachusetts: not listedMAOregon: not listedORNevada: not listedNVWyoming: not listedWYSouth Dakota: not listedSDIowa: not listedIAIndiana: not listedINOhio: not listedOHPennsylvania: not listedPANew Jersey: not listedNJConnecticut: not listedCTCalifornia: not listedCAUtah: not listedUTColorado: not listedCONebraska: not listedNEMissouri: not listedMOKentucky: not listedKYWest Virginia: not listedWVVirginia: not listedVAMaryland: not listedMDDelaware: not listedDEArizona: not listedAZNew Mexico: not listedNMKansas: not listedKSArkansas: not listedARTennessee: not listedTNNorth Carolina: not listedNCSouth Carolina: not listedSCDistrict of Columbia: not listedDCOklahoma: not listedOKLouisiana: not listedLAMississippi: not listedMSAlabama: not listedALGeorgia: not listedGAHawaii: not listedHITexas: not listedTXFlorida: not listedFL

FDA distribution: “US Distribution to: Wisconsin only” States read from FDA’s own wording; “not listed” means the notice does not name it.

States: Wisconsin.

Recall timeline

FDA terminated this recall 18 months after the firm started it.

1. Firm started the recall: May 17, 202112. FDA classified it Class II: Jul 19, 202123. Published in FDA’s Enforcement Report: Jul 28, 202134. FDA terminated the recall: Nov 4, 2022420212022
  1. Firm started the recall
  2. FDA classified it Class II
  3. Published in FDA’s Enforcement Report
  4. FDA terminated the recall

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

✎ GovInfoNow

Questions people ask

Do I need to stop using the monitor immediately?

The recall does not require immediate discontinuation; users should check functionality before use.

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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-2096-2021 (May 17, 2021) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-2096-2021 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.
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