Butterfly iQ Ultrasound System Auto Bladder Volume Tool Recalled for Regulatory Violation
Butterfly Network, Inc. is recalling the Butterfly iQ Ultrasound System Auto Bladder Volume Tool because it was distributed without an approved 510(k).
- Product
- Butterfly iQ Ultrasound System Auto Bladder Volume Tool-The Auto Bladder Volume Tool is a segmentation measurement tool REF/Model: 850-20003 Software versions 1.13.0, 1.14.0, and 1.15.0 - Product Usage: Butterfly iQ is indicated for use by qualified and trained healthcare…
- Category
- Medical Device
- Distribution
- Distributed nationwide