Butterfly iQ Ultrasound System containing the Auto EF — Class II medical device recall Z-1601-2020
Terminated recall by Butterfly Network, Inc., reported 2020-04-08, distributed nationwide. Distributed without an approved 510(k)
| Recall number | Z-1601-2020 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Butterfly Network, Inc., Guilford, CT, United States |
| Recall initiated | 2020-02-24 |
| Classified | 2020-03-27 |
| Reported by FDA | 2020-04-08 |
| Terminated | 2020-06-12 |
| Distributed | Nationwide (US) |
| Quantity | 11,183 |
| Reason classes | unapproved product |
| UPC / GTIN / UDI-DI | 00866646000206 |
| Model numbers | 850-20003 |
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 for recall
Distributed without an approved 510(k)
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1601-2020. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.