🔍 RecallPedia

Diagnostics Ultrasound System Ultrasounds System Sonimage HS1

Class I - Dangerous
🏥 Medical Devices Recalled: April 24, 2017 Konica Minolta Diagnostic Equipment

What Should You Do?

  1. Check if you have this product:
    UDI 04560141940031 04560141944534 04560141945463 04560141946385 V1.31R02 V1.31R04 V1.31R05 V1.31R06 (V131R02 SW and later version)
  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:
Konica Minolta, Inc.
Reason for Recall:
The Doppler velocity measurement on the Sonimage HS1 ultrasound system is not accurate.
Classification:
Class I - Dangerous

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

Status:
terminated

Product Information

Full Description:

Diagnostics Ultrasound System Ultrasounds System Sonimage HS1

Product Codes/Lot Numbers:

UDI 04560141940031 04560141944534 04560141945463 04560141946385 V1.31R02 V1.31R04 V1.31R05 V1.31R06 (V131R02 SW and later version)

Distribution:

Distributed in: CA, CO, KY, FL, NJ, NY, IA, TX, WA

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: Z-2769-2017