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.
Reported: April 8, 2020 Initiated: February 24, 2020 #Z-1600-2020
Product 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.
Reason for Recall
Distributed without an approved 510(k)
Details
- Recalling Firm
- Butterfly Network, Inc.
- Units Affected
- 15,121 host devices
- Distribution
- US Nationwide distribution.
- Location
- Guilford, CT
Frequently Asked Questions
What product was recalled? ▼
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.. Recalled by Butterfly Network, Inc.. Units affected: 15,121 host devices.
Why was this product recalled? ▼
Distributed without an approved 510(k)
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on April 8, 2020. Severity: Moderate. Recall number: Z-1600-2020.
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