Home / Recalls / Butterfly Network, Inc. / Z-1601-2020

Z-1601-2020 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: 11,183

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.

Reason for Recall

Distributed without an approved 510(k)

Distribution Pattern

US Nationwide distribution.

Code Information

Software versions 1.10.0 through 1.15.0