Product Wiki · Recalls · U.S. FDA — Device Enforcement

Recall Z-1601-2020 — 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 structure

U.S. FDA — Device Enforcement · United States · 2020-02-24 · Class II

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-1601-2020
Date of alert
2020-02-24
Country / jurisdiction
United States
Risk level
Class II
Risk type
recall
Brand
Butterfly Network, Inc.
Product category
device
Product type
Devices
Barcode (EAN/GTIN)
00866646000206
Reported risk: Distributed without an approved 510(k)
Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

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