Butterfly iQ Ultrasound System Auto Bladder Volume Tool-The Auto Bladder Volume Tool is a segmentation measurement tool REF/Model: 850-20003 Software versions 1.13.0, 1.14.0, and 1.15.0 - Product Usage: Butterfly iQ is indicated for use by qualified and trained healthcare professionals to enable diagnostic ultrasound imaging and measurement of anatomical structures and fluids of adult and pediatric patients.
Class I - DangerousWhat Should You Do?
- Check if you have this product: Software versions 1.13.0, 1.14.0, and 1.15.0 UDI: (01)00866646000206
- 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:
- Butterfly Network, Inc.
- Reason for Recall:
- Distributed without an approved 510(k)
- Classification:
- Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
- Status:
- terminated
Product Information
Full Description:
Butterfly iQ Ultrasound System Auto Bladder Volume Tool-The Auto Bladder Volume Tool is a segmentation measurement tool REF/Model: 850-20003 Software versions 1.13.0, 1.14.0, and 1.15.0 - Product Usage: Butterfly iQ is indicated for use by qualified and trained healthcare professionals to enable diagnostic ultrasound imaging and measurement of anatomical structures and fluids of adult and pediatric patients.
Product Codes/Lot Numbers:
Software versions 1.13.0, 1.14.0, and 1.15.0 UDI: (01)00866646000206
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: Z-1600-2020
Related Recalls
Distributed without an approved 510(k)