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Recall data is sourced from official U.S. government agencies (CPSC, FDA, NHTSA, USDA) and processed using AI to improve readability. This site is not affiliated with or endorsed by any government agency. Always refer to the original agency notice for authoritative information.

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Medium RiskFDA Device
Medical Devices/Diagnostic Equipment

GE HealthCare MUSE 5 Cardiovascular Systems Recalled for Data Security Risk

Agency Publication Date: June 10, 2025
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Summary

GE Medical Systems Information Technologies Inc (GE HealthCare) is recalling 4,277 MUSE 5 Cardiovascular Information Systems due to a security vulnerability. An administrator account on the system could potentially be accessed through a local network, allowing unauthorized users to change or delete recorded patient medical data. This system is a large-scale computer network used by hospitals to manage and store patient heart health information. No incidents or injuries have been reported, but the defect could lead to incorrect medical records. GE HealthCare has notified users by letter to initiate corrective actions.

Risk

The security flaw allows unauthorized access to the system's administrator account, which could lead to the manipulation of patient health records. If medical data is altered or deleted, doctors may make incorrect diagnoses or treatment decisions based on inaccurate information.

What You Should Do

  1. This recall involves GE HealthCare MUSE 5 Cardiovascular Information Systems, which are client-server computer systems used to manage heart-related data in medical facilities. Affected model numbers include 2021274-001, 2023032-005, and 2027478-001.
  2. Check the model number and serial number on your system label or installation documentation to determine if your device is part of this recall. See the Affected Products section below for the full list of affected codes.
  3. Stop using the recalled device and contact GE HealthCare or your authorized distributor immediately to arrange for a system correction, software patch, or other technical remedy to address the data security risk.
  4. Call the FDA at 1-888-463-6332 (1-888-INFO-FDA) for additional questions regarding this medical device recall.

Your Remedy Options

๐Ÿ“‹Other Action
How to: Stop using the recalled device. Contact the manufacturer or your distributor to arrange return, replacement, or correction.

Affected Products

Product: MUSE 5 Systems
Model / REF:
2021274-001
2023032-005
2027478-001
Serial Numbers (4114):
ABF04400266FA
SAD04390481GA
SAD05091885GA
SAD05091907GA
SAD05091908GA
PA2155054
PA2155057
PA2155059
PA2155061
PA2155063
SAD05302639GA
SAD05302646GA
SAD05322687GA
SAD05322723GA
SAD05322735GA
SAD06524784GA
SAD06204075GA
SAD06204076GA
SAD06204077GA
SAD04380416GA
SAD04380427GA
SAD04430607GA
SAD04440716GA
SAD04440717GA
SAD04440718GA
SAD04440719GA
SAD05453127GA
SAD05453128GA
SAD05453129GA
SAD05453130GA
SAD05453172GA
SAD08105319GA
SAD08105320GA
SAD04501236GA
SAD04501237GA
SAD04501252GA
SAD04501257GA
SAD04501258GA
SAD04350305GA
SAD04350317GA
SAD04350318GA
SAD04350319GA
SAD04350320GA
SAD04350326GA
SAD06424592GA
SAD06444630GA
SAD06454662GA
SAD04491128GA
SAD04491129GA
SAD04491130GA

Recall #: Z-1938-2025

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 96830
Status: Active
Manufacturer: GE Medical Systems Information Technologies Inc
Sold By: GE HealthCare authorized distributors; Medical equipment suppliers
Manufactured In: United States
Units Affected: 4,277 systems
Distributed To: Nationwide

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

Find an Attorney

This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES ยท Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.