🔍 RecallPedia

SOZO Bilateral Arm L-Dex Software

Class I - Dangerous
🏥 Medical Devices Recalled: August 17, 2023 Impedimed Limited Other Medical Devices Nationwide

What Should You Do?

  1. Check if you have this product:
    UDI-DI: B277SFT0250. Software v4.1 and v5.0
  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:
Impedimed Limited
Reason for Recall:
Bilateral L-Dex assessment software does not have the same level of sensitivity to help detect early signs of lymphedema as the unilateral arm L-Dex assessment, which could result in under-recognition of early lymphedema, which could result in delay in early intervention, and more aggressive intervention.
Classification:
Class I - Dangerous

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

Status:
ongoing

Product Information

Full Description:

SOZO Bilateral Arm L-Dex Software

Product Codes/Lot Numbers:

UDI-DI: B277SFT0250. Software v4.1 and v5.0

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: Z-0155-2024