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Lower risk Medical device recall · FDA · Published March 28, 2018

Draegar Infinity Acute Care System: Software Issue Causes Data Loss

Draegar Medical recalls Infinity Acute Care System monitoring devices due to software anomaly that may cause loss of patient settings and stored medical data. Affected models include MS20401, MS20724, etc.

🇺🇸 FDA recall #Z-1813-2018Medical deviceDraegar Medical ›
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Recalling firmDraegar Medical Systems, Inc.6 Tech Dr · Andover, MA 01810-2434
✎ GovInfoNow plain-language explainer

What happened, in plain English

Draegar Medical is recalling certain Infinity Acute Care System monitoring devices because of a software issue that could cause patient settings and medical data to be lost. This affects healthcare providers using the devices for patient monitoring in clinical settings. Read more at govinfonow.com/recall/71589-draegar-infinity-acute-care-system-software-issue-causes-data-loss.

Source Summary by GovInfoNow · govinfonow.com/recall/71589-draegar-infinity-acute-care-system-software-issue-causes-data-loss · Updated August 21, 2026 · FDA enforcement record: FDA #Z-1813-2018

Cite this page

“Draegar Infinity Acute Care System: Software Issue Causes Data Loss.” GovInfoNow, updated August 21, 2026. https://govinfonow.com/recall/71589-draegar-infinity-acute-care-system-software-issue-causes-data-loss. Based on FDA recall #Z-1813-2018 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1813-2018%22&limit=1).

Why it’s dangerous

The software anomaly causes the system to lose patient settings and stored medical data. This could lead to incomplete patient records or missed critical information during medical monitoring. However, the issue does not pose a direct risk to patient safety or cause physical harm.

Who’s affected

Healthcare professionals using the Infinity Acute Care System monitoring devices for patient care. Patients are not directly affected as the issue is with the monitoring system's software, not patient safety.

How to tell if you have this one

Check for catalog numbers MS20401, MS20724, MS22956, MS25510, MS25520, MS25643, MS26196, MS26372, or MS31818 on the device. The devices are used in clinical settings by healthcare professionals for monitoring patients.

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

What to do — step by step

  1. Check Device Catalog Number

    Look for the catalog numbers MS20401, MS20724, MS22956, MS25510, MS25520, MS25643, MS26196, MS26372, or MS31818 on the device label.

Where it went and when

Where it was distributed

Distributed nationwide, and outside the U.S.

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: “Worldwide Distribution - USA (nationwide) and to the countries of : Angola, Argentina, Australia Austria Azerbaijan Bahrain Belgium Bolivia Brazil Brunei Dar-es-S Canada Chile China Colombia Costa Rica Czech Republic Denmark Egypt Finland…” 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 terminated this recall 2.1 years after the firm started it.

1. Firm started the recall: Mar 28, 201812. FDA classified it Class II: May 14, 201823. Published in FDA’s Enforcement Report: May 23, 201834. FDA terminated the recall: Apr 21, 2020420182020
  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-1813-2018 (March 28, 2018) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1813-2018 to see it in context.
  • Plain-language summary written by qwen3:4b on August 21, 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