FDA Medical Device Recalls (openFDA)
Butterfly Network, Inc.: 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.
- Recall number
- Z-1601-2020
- 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.
- Status
- Terminated
- Initiated
- 2020-02-24
- Posted
- 2020-03-17
- Terminated
- 2020-06-12
- Reason
- Distributed without an approved 510(k)
- 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 Support@butterflynetwork.com
- Quantity
- 11,183
- Distribution
- US Nationwide distribution.
- Lot, serial or model codes
- Software versions 1.10.0 through 1.15.0
- 510(k) numbers
- ["K163510"]
- PMA numbers
- not on file
- Product code
- IYN
- Firm FEI
- 3010102386
- Firm city
- Guilford
- Firm state
- CT
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28