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Butterfly Network, Inc. recalls Butterfly iQ Ultrasound System containing the Auto EF(Ejection Fraction) Tool REF/Model: 850-20003 UDI: (01)0086664600
Recalled April 8, 2020 · FDA recall Z-1601-2020 · Butterfly Network
Hazard
Distributed without an approved 510(k) · FDA Class II
Units
11,183
Sold at
US Nationwide distribution.
Description
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.
Manufacturer(s)
Butterfly Network, Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →