GE Healthcare Vivid S60, ultrasound device

Class I - Dangerous

What Should You Do?

  1. Check if you have this product:
    Software versions: v203, v204
  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 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.
Classification:
Class I - Dangerous

Dangerous or defective products that predictably could cause serious health problems or death.

Status:
ongoing

Product Information

Full Description:

GE Healthcare Vivid S60, ultrasound device

Product Codes/Lot Numbers:

Software versions: v203, v204

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: Z-2124-2023

Related Recalls

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.

May 2, 2024 Infusion Pumps View Details →
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.

May 30, 2023 Infusion Pumps View Details →