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Lower risk Medical device recall · FDA · Published May 19, 2021

Caption Health Software Version 1.2.0 May Cause Incorrect Heart Measurements

Caption Health recalls ultrasound software version 1.2.0 due to potential incorrect heart measurement calculations. Affected users should check their software version and contact the company for updates.

Plain-English summary generated from official FDA data by GovInfoNow · Published by Carlos Caban · How we make summaries

🇺🇸 FDA recall #Z-2111-2021Medical deviceCaption Health ›
Take action

Contact the company

Recalling firmCaption Health2000 Sierra Point Pkwy Fl 8 · Brisbane, CA 94005-1845
✎ GovInfoNow plain-language explainer

Caption Health is recalling a specific version of their ultrasound imaging software that may produce inaccurate heart measurements. This could lead to incorrect medical assessments if used without correction. Read more at govinfonow.com/recall/62521-caption-health-software-version-1-2-0-may-cause-incorrect.

Source Summary by GovInfoNow · govinfonow.com/recall/62521-caption-health-software-version-1-2-0-may-cause-incorrect · Updated August 19, 2026 · FDA enforcement record: FDA #Z-2111-2021

Cite this page

“Caption Health Software Version 1.2.0 May Cause Incorrect Heart Measurements.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/62521-caption-health-software-version-1-2-0-may-cause-incorrect. Based on FDA recall #Z-2111-2021 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2111-2021%22&limit=1).

The FDA announced on May 19, 2021, that Caption Health recalled Version: 1.2.0 (1.2.0+85ela410) of its Caption AI Ultrasound Imaging System Application Software due to a hazard involving unintended video frames. This software defect could lead to incorrect automated ejection fraction and image quality score estimates for the affected systems.

How to tell if you have it

  • Caption Health, Caption AI, Ultrasound Imaging System Application Software, Version: 1.2.0 (1.2.0+85ela410), GMDN: 40873, UPC: 00860003586303

The hazard

According to the FDA, the ultrasound software issue results in unintended video frames being included. This could lead to an incorrect automated ejection fraction (AutoEF) and image quality score (IQS) estimates.

Context

GovInfoNow's records show other recent recalls of similar products include Midmark ECG Devices May Show Incorrect Heart Rhythm Readings (2026-07-20), Philips EPIQ Elite Ultrasound System Recall: Inaccurate Blood Flow Measurements (2026-08-07), and Philips Cardiac Workstation 5000: Inaccurate Heart Rate Data Risk (2026-07-01).

How to tell if you have this one

Check if your ultrasound imaging software shows version 1.2.0 (1.2.0+85ela410). The recall applies to all products with this specific software version.

  • Brand
    Caption Health
  • Product
    Version: 1.2.0 (1.2.0+85ela410) Caption Health, Caption AI, Ultrasound Imaging System Application Software (GMDN
  • Category
    Medical device
Based on the official FDA remedy

What to do — step by step

  1. Check Software Version

    Verify your ultrasound imaging software version to see if it matches 1.2.0 (1.2.0+85ela410).

Where it went and when

Where it was distributed

Distributed in 5 states.

Alaska: not listedAKMaine: not listedMEVermont: not listedVTNew Hampshire: not listedNHWashington: not listedWAIdaho: not listedIDMontana: not listedMTNorth Dakota: not listedNDMinnesota: not listedMNIllinois: yesILWisconsin: not listedWIMichigan: not listedMINew York: yesNYRhode 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: yesCTCalifornia: not listedCAUtah: not listedUTColorado: not listedCONebraska: not listedNEMissouri: not listedMOKentucky: not listedKYWest Virginia: not listedWVVirginia: not listedVAMaryland: not listedMDDelaware: yesDEArizona: yesAZNew 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 : AZ, DE, NY, IL, CT OUS: None” States read from FDA’s own wording; “not listed” means the notice does not name it.

States: Arizona, Connecticut, Delaware, Illinois, New York.

Recall timeline

FDA terminated this recall 20 months after the firm started it.

1. Firm started the recall: May 19, 202112. FDA classified it Class II: Jul 22, 202123. Published in FDA’s Enforcement Report: Jul 28, 202134. FDA terminated the recall: Jan 31, 2023420212023
  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-2111-2021 (May 19, 2021) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-2111-2021 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