Butterfly iQ Ultrasound System containing the Auto… recallZ-1601-2020 · Butterfly Network, Inc. · initiated Feb 24, 2020
Class II Terminated All recalls posted in March 2020
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Butterfly Network, Inc. or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
Distributed without an approved 510(k)
FDA root cause category: No Marketing Application
What the company is doing
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]
Recall details
- Recall number
- Z-1601-2020
- Recall class
- Class II
- Status
- Terminated
- Initiated by the company
- Feb 24, 2020
- Posted by the FDA
- Mar 17, 2020
- Recalling firm
- Butterfly Network, Inc.
- Quantity
- 11,183
- Product code
- IYN
- FDA submissions
- K163510
- Distribution
- US Nationwide distribution.
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.
Code information (models, lots, serial numbers)
Software versions 1.10.0 through 1.15.0
Other devices under the same FDA submission
1 device cleared under K163510 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.
- BUTTERFLY iQ/iQ+ WIRELESS CHARGER KIT WTD1A05Butterfly Network, Inc. · System, imaging, pulsed doppler, ultrasonic1 report
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 18, 2026. Text above is shown as published by the FDA.
How recalls are matched to devices · Editorial policy · Report an error on this page