medical Class II Updated 2020-04-08

Butterfly Network, Inc. recalls Butterfly iQ Ultrasound System containing the Auto EF(Ejecti

Recalled 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.


Hazard / Issue

Distributed without an approved 510(k)

Issued by

FDA

Distribution: Nationwide (United States)
Lot/Code Info: Software versions 1.10.0 through 1.15.0
View official government recall

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