medical Class II Updated 2020-04-08

Butterfly Network, Inc. recalls Butterfly iQ Ultrasound System Auto Bladder Volume Tool-The

Recalled 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.

Hazard / Issue

Distributed without an approved 510(k)

Issued by

FDA

Distribution: Nationwide (United States)
Lot/Code Info: Software versions 1.13.0, 1.14.0, and 1.15.0 UDI: (01)00866646000206
View official government recall

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