Butterfly iQ Ultrasound System Recalled for Lack of FDA Approval
Butterfly Network, Inc. is recalling 11,183 Butterfly iQ Ultrasound Systems because they were 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…
- Category
- Medical Device
- Distribution
- Distributed nationwide