Z-1601-2020Class II

Butterfly iQ Ultrasound System containing the Auto EF(Ejection Fraction) Tool REF/Model: 850-20003 UDI...

Name: Z-1601-2020 Butterfly iQ Ultrasound System containing the Auto EF(Ejection Fraction) Tool REF/Model: 850-20003 UDI...
Creator: Butterfly Network, Inc.
Published: 2020-02-24
License: https://open.fda.gov/license/

Butterfly Network, Inc. / initiated 2020-02-24 / Terminated

FDA source

Butterfly Network, Inc. began a recall of 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... on 2020-02-24. FDA classified it as Class II and gives the reason as "Distributed without an approved 510(k)". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-1601-2020
Classification: Class II
Status: Terminated
Initiated: 2020-02-24
Posted: 2020-03-17
Terminated: 2020-06-12
Recalling firm: Butterfly Network, Inc.
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.
Product code: IYN System, Imaging, Pulsed Doppler, Ultrasonic
Reason for recall: Distributed without an approved 510(k)
FDA root cause: No Marketing Application
Action: Butterfly Network issued a correction notification via email on February 24, 2020 disabling the Auto EF Tool from affected devices operating software versions 1.10.0 through 1.15.0 for all affected US Butterfly iQ users and removed references of the Auto EF Tool from outward marketing platforms. Butterfly Network has notified Affiliate partners to cease marketing the Auto EF Volume Tool until further notice. Questions related to this correction can be sent to Butterfly Network Customer Support via email at [email protected]
Quantity in commerce: 11,183
Distribution: US Nationwide distribution.
Product codes and lots: Software versions 1.10.0 through 1.15.0

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1601-2020
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1601-2020	Class II	Terminated	Voluntary: Firm initiated	2020-04-08	2020-03-27

Product code IYN

K163510Class IIPoseidon Ultrasound SystemButterfly Network, Inc. / cleared 2017-09-06

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)