Butterfly Network, Inc.: Medical Device Recall in 2020 - (Recall #: Z-1600-2020)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2020.

Data Source: FDA.

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.

Product Classification:

Class II

Date Initiated: February 24, 2020

Date Posted: April 8, 2020

Recall Number: Z-1600-2020

Event ID: 85185

Reason for Recall:

Distributed without an approved 510(k)

Status: Terminated

Product Quantity: 15,121 host devices

Code Information:

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

Distribution Pattern:

US Nationwide distribution.

Voluntary or Mandated:

Voluntary: Firm initiated