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Lower risk Medical device recall · FDA · Published March 16, 2022

GE Healthcare MUSE Cardiology System Recall: Data Loss Risk After Test Sign-off

GE Healthcare recalls specific MUSE Cardiology Information System models due to risk of lost test measurements and diagnosis statements after signing in the web client. Affected units have unique serial numbers and model identifiers.

🇺🇸 FDA recall #Z-0919-2022Medical deviceGE Healthcare ›
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Contact the company

Recalling firmGE Healthcare, LLC3000 N Grandview Blvd · Waukesha, WI 53188-1615
✎ GovInfoNow plain-language explainer

What happened, in plain English

GE Healthcare is recalling certain MUSE Cardiology Information System models because edits to measurements and diagnosis statements can be lost after a test is signed in the web client. This could lead to incorrect medical data being used in patient care. Read more at govinfonow.com/recall/60925-ge-healthcare-muse-cardiology-system-recall-data-loss-risk-after.

Source Summary by GovInfoNow · govinfonow.com/recall/60925-ge-healthcare-muse-cardiology-system-recall-data-loss-risk-after · Updated August 17, 2026 · FDA enforcement record: FDA #Z-0919-2022

Cite this page

“GE Healthcare MUSE Cardiology System Recall: Data Loss Risk After Test Sign-off.” GovInfoNow, updated August 17, 2026. https://govinfonow.com/recall/60925-ge-healthcare-muse-cardiology-system-recall-data-loss-risk-after. Based on FDA recall #Z-0919-2022 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0919-2022%22&limit=1).

Why it’s dangerous

The system may lose edited measurements and diagnosis statements after a test is signed in the web client. This could result in incorrect medical data being used for patient care decisions.

Who’s affected

Healthcare providers using the recalled MUSE Cardiology Information System models are most at risk. Patients receiving care through these systems may be affected if the system loses critical test data.

How to tell if you have this one

Check for model numbers: 3101011-040, 3101010-401, 3101010-009, or 3101010-008. Affected units have specific serial numbers listed in the recall notice.

  • Brand
    GE Healthcare
  • Product
    GE Healthcare, LLC recalls MUSE Cardiology Information System, Model Numbers: a) 3101011-040, b) 3101010-401, c) 3101010-009, d) 3101010-008
  • Category
    Medical device
Based on the official FDA remedy

What to do — step by step

  1. Check Product Model

    Identify your MUSE Cardiology Information System model number from the product label.

  2. Verify Serial Numbers

    Compare your serial numbers with the list provided in the recall notice to confirm if your unit is affected.

How this recall unfolded

Recall timeline

FDA terminated this recall 4.1 years after the firm started it.

1. Firm started the recall: Mar 16, 202212. FDA classified it Class II: Apr 13, 202223. Published in FDA’s Enforcement Report: Apr 20, 202234. FDA terminated the recall: May 4, 2026420222026
  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-0919-2022 (March 16, 2022) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0919-2022 to see it in context.
  • Plain-language summary written by qwen3:4b on August 17, 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