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Lower risk Medical device recall · FDA · Published May 15, 2020

Mediana Attendant Vital Signs Monitor Recall: Temperature Measurement Failure

Mediana recalls vital signs monitor model AVSM2 due to temperature measurement failures in predict mode. Affected units have serial numbers 4568020:000001-456802000180.

🇺🇸 FDA recall #Z-2441-2020Medical deviceMediana ›
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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 AVSM2 vital signs monitor because temperature measurements can fail during predict mode. This could lead to inaccurate vital signs readings, potentially affecting patient care. Read more at govinfonow.com/recall/65141-mediana-attendant-vital-signs-monitor-recall-temperature-measurement-failure.

Source Summary by GovInfoNow · govinfonow.com/recall/65141-mediana-attendant-vital-signs-monitor-recall-temperature-measurement-failure · Updated August 19, 2026 · FDA enforcement record: FDA #Z-2441-2020

Cite this page

“Mediana Attendant Vital Signs Monitor Recall: Temperature Measurement Failure.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/65141-mediana-attendant-vital-signs-monitor-recall-temperature-measurement-failure. Based on FDA recall #Z-2441-2020 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2441-2020%22&limit=1).

Why it’s dangerous

The monitor's temperature measurement function fails when in predict mode, which is a mode used for forecasting vital signs trends. This could result in incorrect temperature readings for patients, potentially impacting clinical decisions.

Who’s affected

Healthcare facilities using the Mediana AVSM2 monitor with serial numbers 456802000001 to 456802000180 are affected. Staff monitoring patients with this device are at risk of inaccurate temperature readings.

How to tell if you have this one

Check if your monitor has the serial number range 456802000001 to 456802000180. The product is a vital signs monitor used in hospitals for noninvasive blood pressure, oxygen saturation, pulse rate, and temperature measurements.

  • Brand
    Mediana
  • Category
    Medical device
Based on the official FDA remedy

What to do — step by step

  1. Check Serial Number

    Verify your monitor's serial number falls within the range 456802000001 to 456802000180.

Where it went and when

Where it was distributed

Distributed nationwide.

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

Distributed nationwide.

Recall timeline

FDA terminated this recall 2.3 years after the firm started it.

1. Firm started the recall: May 15, 202012. FDA classified it Class II: Jun 26, 202023. Published in FDA’s Enforcement Report: Jul 8, 202034. FDA terminated the recall: Sep 16, 2022420202022
  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.

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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-2441-2020 (May 15, 2020) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-2441-2020 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