🔍 RecallPedia

bkActiv Ultrasound System 2300, Model numbers 2300-56 and 2300-66.

Class I - Dangerous
🏥 Medical Devices Recalled: November 30, 2023 B-K Medical A/S Infusion Pumps Nationwide

What Should You Do?

  1. Check if you have this product:
    All bkActive (2300-56 and 2300-66) Ultrasound systems, GTIN 05704916000264.
  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:
B-K Medical A/S
Reason for Recall:
An issue on the Dual Live Compare feature on the bkActiv system could result in a measurement error.
Classification:
Class I - Dangerous

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

Status:
ongoing

Product Information

Full Description:

bkActiv Ultrasound System 2300, Model numbers 2300-56 and 2300-66.

Product Codes/Lot Numbers:

All bkActive (2300-56 and 2300-66) Ultrasound systems, GTIN 05704916000264.

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: Z-0813-2024

Related Recalls