GE Vivid Ultrasound products, Model Numbers: a) Vivid S70, H45041SW

Class I - Dangerous

What Should You Do?

  1. Check if you have this product:
    a) H45041SW, UDI/DI *, Serial Numbers: 001423S70
  2. Do not eat it: Even if it looks and smells fine, do not consume this product.
  3. Throw it away or return it: You can return the product to the store for a full refund.
  4. Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
  5. 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.gov

FDA Recall Number: Z-2317-2024

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Class I - Dangerous

GE HealthCare has become aware that certain Vivid ultrasound systems cannot boot up in a timely fashion. If this occurs, it can delay availability of the device in time-critical emergency situations.

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