# FDA recall Z-1601-2020

> **Butterfly Network, Inc.** · Class II · device recall initiated 2020-02-24.

## 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)

## Distribution

US Nationwide distribution.

## Key facts

- **Recall number:** Z-1601-2020
- **Recalling firm:** Butterfly Network, Inc.
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2020-02-24
- **Report date:** 2020-04-08
- **Termination date:** 2020-06-12

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Guilford, CT, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1601-2020

## Citation

> AI Analytics. FDA recall Z-1601-2020. Retrieved 2026-06-02 from https://api.ai-analytics.org/recall/Z-1601-2020. Source: US FDA. Licensed CC0.

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