GE Vivid Ultrasound products, Model Numbers: a) Vivid S70, H45041SW
Class I - DangerousWhat Should You Do?
- Check if you have this product: a) H45041SW, UDI/DI *, Serial Numbers: 001423S70
- Do not eat it: Even if it looks and smells fine, do not consume this product.
- Throw it away or return it: You can return the product to the store for a full refund.
- Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
- Report problems: Report any issues to the FDA's Safety Reporting Portal.
⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.
Recall Details
- Company:
- GE Vingmed Ultrasound As
- Reason for Recall:
- GE HealthCare has become aware of an issue with certain Vivid ultrasound systems where, due to a slow DICOM Worklist response time, incorrect patient name and demographics can be displayed on the ultrasound scanner screen rather than the intended patient selected by the user.
- Classification:
- Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
- Status:
- ongoing
Product Information
Full Description:
GE Vivid Ultrasound products, Model Numbers: a) Vivid S70, H45041SW
Product Codes/Lot Numbers:
a) H45041SW, UDI/DI *, Serial Numbers: 001423S70
Distribution:
Distributed in: US, IL, MA, NM, NY, OK
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: Z-2317-2024
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