Recall Z-1601-2020— Butterfly Network, Inc.

Name: FDA recall Z-1601-2020
Creator: U.S. Food and Drug Administration
Published: 2020-02-24

Class II · Terminated

Class II FDA medical device recall by Butterfly Network, Inc., initiated 2020-02-24, terminated 2020-06-12. It names one FDA 510(k) clearance: K163510. Product: 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: Distributed without an approved 510(k).

Recalling firm: Butterfly Network, Inc.
Classification: Class II
Status: Terminated
Initiated: 2020-02-24
Terminated: 2020-06-12
Firm location: Guilford, CT, United States

510(k) clearances named in this recall

1 on FDA's record

K163510 — Poseidon Ultrasound SystemButterfly Network, Inc.·cleared 2017-09-06

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

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)

Data sourced from openFDA. This site is unofficial and independent of the FDA.