Butterfly Network, Inc.: Medical Device Recall in 2020 - (Recall #: Z-1601-2020)

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 containing the Auto EF(Ejection Fraction) Tool REF/Model: 850-20003 UDI: (01)00866646000206 Software versions 1.10.0, 1.11.0, 1.12.0, 1.13.0, 1.13.0, 1.14.0, 1.15.0 Product Usage: Intended use: Diagnostic ultrasound imaging and measurement of anatomical structures.

Product Classification:

Class II

Date Initiated: February 24, 2020

Date Posted: April 8, 2020

Recall Number: Z-1601-2020

Event ID: 85178

Reason for Recall:

Distributed without an approved 510(k)

Status: Terminated

Product Quantity: 11,183

Code Information:

Software versions 1.10.0 through 1.15.0

Distribution Pattern:

US Nationwide distribution.

Voluntary or Mandated:

Voluntary: Firm initiated