LOGIQ P9 R4.5 ultrasound system with system software version R4.5.7., Model Number 5877533
Class I - DangerousWhat Should You Do?
- Check if you have this product: Model 5877533 UDI-DI: 00195278464637, Serial Numbers: LP9490416 LP9490175 LP9490393 LP9490399 LP9490376 LP9490463 LP9443017 LP9442472 LP9443231 LP9442094 LP9443291 LP9443230 LP9440403 LP9442483 LP9440972 LP9440166 LP9440237 LP9440933 LP9440348 LP9442196 LP9440631 LP9440926 LP9441099 LP9441225 LP9441097 LP9440929 LP9441030 LP9440921 LP9441035 LP9440507 LP9440920 LP9440459 LP9440460 LP9441332 LP9442656 LP9443022 LP9440986
- Do not eat it: Even if it looks and smells fine, do not consume this product.
- Throw it away or return it: You can return the product to the store for a full refund.
- Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
- 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 Medical Systems, LLC
- Reason for Recall:
- The Ultrasound-Guided Attenuation Parameter (UGAP) measurement data may display inaccurate values representing liver steatosis. This could potentially lead to inappropriate clinical decisions impacting overall care.
- Classification:
- Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
- Status:
- ongoing
Product Information
Full Description:
LOGIQ P9 R4.5 ultrasound system with system software version R4.5.7., Model Number 5877533
Product Codes/Lot Numbers:
Model 5877533 UDI-DI: 00195278464637, Serial Numbers: LP9490416 LP9490175 LP9490393 LP9490399 LP9490376 LP9490463 LP9443017 LP9442472 LP9443231 LP9442094 LP9443291 LP9443230 LP9440403 LP9442483 LP9440972 LP9440166 LP9440237 LP9440933 LP9440348 LP9442196 LP9440631 LP9440926 LP9441099 LP9441225 LP9441097 LP9440929 LP9441030 LP9440921 LP9441035 LP9440507 LP9440920 LP9440459 LP9440460 LP9441332 LP9442656 LP9443022 LP9440986
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: Z-0157-2026
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