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Butterfly Network, Inc. recalls Butterfly iQ Ultrasound System Auto Bladder Volume Tool-The Auto Bladder Volume Tool is a segmentation measurement tool
Recalled April 8, 2020 · FDA recall Z-1600-2020 · Butterfly Network
Hazard
Distributed without an approved 510(k) · FDA Class II
Units
15,121 host devices
Sold at
US Nationwide distribution.
Description
Distributed without an approved 510(k)
Product
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.
Manufacturer(s)
Butterfly Network, Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →