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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 Vingmed Ultrasound As: Vivid Ultrasound Systems Recalled for Potential Display of Incorrect Patient Data

Agency Publication Date: July 5, 2024
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Summary

GE HealthCare has recalled 8 GE Vivid Ultrasound systems, specifically models Vivid E90, E95, and S70, because of a technical software issue. A slow response time in the system's patient data list can cause the screen to display the incorrect patient's name and demographics instead of the patient currently being scanned. This defect was identified in units distributed across Illinois, Massachusetts, New Mexico, New York, and Oklahoma. Consumers and healthcare providers should contact the manufacturer or their healthcare provider for further instructions regarding this recall.

Risk

If the wrong patient profile is displayed on the screen, medical professionals may inadvertently perform an ultrasound or record diagnostic data under the incorrect patient record. This mismatch of information poses a risk of misdiagnosis or improper medical treatment based on inaccurate patient demographics.

What You Should Do

  1. Identify if your device is affected by checking the model and serial numbers. Affected Vivid E90 units have serial numbers AU01170, AU01180, or AU50159. Affected Vivid E95 units have serial numbers AU01095, AU50476, AU50252, or AU01002. The affected Vivid S70 unit has serial number 001423S70.
  2. Verify that the patient name and demographics displayed on the ultrasound scanner screen match the intended patient before beginning any scan or diagnostic procedure.
  3. Contact your healthcare provider or the manufacturer, GE Vingmed Ultrasound As, to discuss the specific issue and receive further instructions on necessary software updates or corrections.
  4. If you have additional questions, contact the FDA at 1-888-463-6332 (1-888-INFO-FDA) or visit the official website at www.fda.gov/medical-devices/medical-device-recalls.

Your Remedy Options

๐Ÿ“‹Other Action

Contact the manufacturer for technical correction or guidance.

How to: Contact your healthcare provider or the manufacturer for further instructions and potential refund

Affected Products

Product: GE Vivid Ultrasound Vivid E90
Model / REF:
H45581LB
Lot Numbers:
AU01170
AU01180
AU50159
Product: GE Vivid Ultrasound Vivid E95
Model / REF:
H45581DA
H45581D
Lot Numbers:
AU01095
AU50476
AU50252
AU01002
Product: GE Vivid Ultrasound Vivid S70
Model / REF:
H45041SW
Lot Numbers:
001423S70

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 94772
Status: Active
Manufacturer: GE Vingmed Ultrasound As
Sold By: Authorized distributors; Medical facilities
Manufactured In: Norway
Units Affected: 2 products (7 units; 1 unit)
Distributed To: Illinois, Massachusetts, New Mexico, New York, Oklahoma

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.