Recall Z-1600-2020— Butterfly Network, Inc.
Class II · Terminated
Class II FDA medical device recall by Butterfly Network, Inc., initiated 2020-02-24, terminated 2020-06-12. It names one FDA 510(k) clearance: K163510. 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 professionals to enable diagnostic ultrasound imaging and measurement of anatomical structures and fluids of adult and pediatric patients.. Reason: Distributed without an approved 510(k).
- Recalling firm
- Butterfly Network, Inc.
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2020-02-24
- Terminated
- 2020-06-12
- Firm location
- Guilford, CT, United States
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
Product description
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 professionals to enable diagnostic ultrasound imaging and measurement of anatomical structures and fluids of adult and pediatric patients.
Reason for recall
Distributed without an approved 510(k)
Data sourced from openFDA. This site is unofficial and independent of the FDA.