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Lower risk Medical device recall · FDA · Published March 8, 2023

Radiometer AQURE System Software Versions 2.5.2-2.6.1 May Cause Patient Data Mix-Up

Radiometer recalls AQURE REF 933-599 software versions 2.5.2 through 2.6.1 due to potential patient information mix-ups. Affected medical devices may require software updates to prevent errors in patient data management.

🇺🇸 FDA recall #Z-1394-2023Medical deviceRadiometer ›
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Recalling firmRadiometer Medical ApSAkandevej 21 · Bronshoj, Denmark
✎ GovInfoNow plain-language explainer

What happened, in plain English

Radiometer is recalling specific software versions of its AQURE system for medical use. The issue could lead to patient information mix-ups, which might cause errors in medical testing and reporting. Read more at govinfonow.com/recall/58776-radiometer-aqure-system-software-versions-2-5-2-2-6.

Source Summary by GovInfoNow · govinfonow.com/recall/58776-radiometer-aqure-system-software-versions-2-5-2-2-6 · Updated August 19, 2026 · FDA enforcement record: FDA #Z-1394-2023

Cite this page

“Radiometer AQURE System Software Versions 2.5.2-2.6.1 May Cause Patient Data Mix-Up.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/58776-radiometer-aqure-system-software-versions-2-5-2-2-6. Based on FDA recall #Z-1394-2023 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1394-2023%22&limit=1).

Why it’s dangerous

The software issue could cause patient data to be mixed up during testing, potentially leading to incorrect medical results. This might happen if the system fails to properly link patient information with test results.

Who’s affected

Healthcare professionals using the AQURE system for patient data management are most at risk. The recall affects medical devices sold to hospitals and clinics that use these software versions.

How to tell if you have this one

Check if your AQURE system has model number 933-599 and software versions 2.5.2 through 2.6.1. The system is used in medical settings for managing patient data and test results.

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

What to do — step by step

  1. Check Software Version

    Identify your AQURE system's software version by checking the device settings or documentation.

  2. Update Software

    Contact Radiometer to get the latest software update to fix the patient data mix-up issue.

Where it went and when

Where it was distributed

Distributed nationwide and abroad; the notice names 40 states.

Alaska: nationwideAKMaine: named in the noticeMEVermont: nationwideVTNew Hampshire: named in the noticeNHWashington: named in the noticeWAIdaho: nationwideIDMontana: named in the noticeMTNorth Dakota: named in the noticeNDMinnesota: named in the noticeMNIllinois: named in the noticeILWisconsin: named in the noticeWIMichigan: named in the noticeMINew York: named in the noticeNYRhode Island: nationwideRIMassachusetts: named in the noticeMAOregon: named in the noticeORNevada: nationwideNVWyoming: nationwideWYSouth Dakota: named in the noticeSDIowa: nationwideIAIndiana: named in the noticeINOhio: named in the noticeOHPennsylvania: named in the noticePANew Jersey: named in the noticeNJConnecticut: named in the noticeCTCalifornia: named in the noticeCAUtah: named in the noticeUTColorado: named in the noticeCONebraska: named in the noticeNEMissouri: named in the noticeMOKentucky: named in the noticeKYWest Virginia: named in the noticeWVVirginia: named in the noticeVAMaryland: named in the noticeMDDelaware: nationwideDEArizona: named in the noticeAZNew Mexico: named in the noticeNMKansas: named in the noticeKSArkansas: named in the noticeARTennessee: named in the noticeTNNorth Carolina: named in the noticeNCSouth Carolina: named in the noticeSCDistrict of Columbia: nationwideDCOklahoma: named in the noticeOKLouisiana: named in the noticeLAMississippi: nationwideMSAlabama: named in the noticeALGeorgia: named in the noticeGAHawaii: nationwideHITexas: named in the noticeTXFlorida: named in the noticeFL

FDA distribution: “Worldwide - U.S. Nationwide including in the states of AL, AR, AZ, CA, CO, CT, FL, GA, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MT, NC, ND, NE, NH, NJ, NM, NY, OH, OK, OR, PA, SC, SD, TN, TX, UT, VA, WA, WI, and WV. The countries of…” States read from FDA’s own wording; “not listed” means the notice does not name it.

Named in the notice: Alabama, Arizona, Arkansas, California, Colorado, Connecticut, Florida, Georgia, Illinois, Indiana, Kansas, Kentucky, Louisiana, Maine, Maryland, Massachusetts, Michigan, Minnesota, Missouri, Montana, Nebraska, New Hampshire, New Jersey, New Mexico, New York, North Carolina, North Dakota, Ohio, Oklahoma, Oregon, Pennsylvania, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Washington, West Virginia, Wisconsin.

Recall timeline

FDA published this recall 49 days after the firm started it.

1. Firm started the recall: Mar 8, 202312. FDA classified it Class II: Apr 17, 202323. Published in FDA’s Enforcement Report: Apr 26, 202332023
  1. Firm started the recall
  2. FDA classified it Class II
  3. 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-1394-2023 (March 8, 2023) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1394-2023 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