FDAFDA · Food and drugs·Recall number Z-1600-2020
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.
Published April 8, 2020 · Recall initiated: February 24, 2020
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Distributed without an approved 510(k)
What to do
Voluntary: Firm initiated · E-Mail
Recall details
- Manufacturer
- Butterfly Network, Inc.
- Distributor
- US Nationwide distribution.
- Lot
- Software versions 1.13.0, 1.14.0, and 1.15.0 UDI: (01)00866646000206
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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