Class II — Butterfly Network, Inc.
| Recalling firm | Butterfly Network, Inc. |
|---|---|
| Registered facility | BUTTERFLY NETWORK, INC. (the firm's only registered facility) |
| Classification | Class II |
| Status | Terminated |
| Reason | Distributed without an approved 510(k) |
| 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. |
| Quantity | 11,183 |
| Distribution | US Nationwide distribution. |
| Initiated | 2020-02-24 |
| Classified | 2020-03-27 |
| Terminated | 2020-06-12 |
| Recall number | Z-1601-2020 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class II recall — Butterfly Network, Inc. (Z-1601-2020).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/85178/
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