Home / Recalls / Butterfly Network, Inc. / Z-1600-2020

Z-1600-2020 Class II Terminated

Recalled by Butterfly Network, Inc. — Guilford, CT

Recall Details

Product Type
Devices
Report Date
April 8, 2020
Initiation Date
February 24, 2020
Termination Date
June 12, 2020
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
15,121 host devices

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)

Distribution Pattern

US Nationwide distribution.

Code Information

Software versions 1.13.0, 1.14.0, and 1.15.0 UDI: (01)00866646000206

Other recalls by Butterfly Network, Inc.

  • Z-1601-2020 Class II — Butterfly iQ Ultrasound System containing the Auto EF(Ejection Fraction) Tool R (February 24, 2020)