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
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