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.
Recall
- Recall Number
- Z-1600-2020
- Event Number
- 85185
- Firm
- Butterfly Network, Inc.
- FEI Number
- 3010102386
- Product Code
- IYN
- Status
- Terminated
- Root Cause
- No Marketing Application
- Initiated
- February 24, 2020
- Posted
- March 17, 2020
- Terminated
- June 12, 2020
- Address
- 530 Old Whitfield St, Guilford, CT, 06437-3441
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.
Distributed without an approved 510(k)
Butterfly Network issued a correction notification via email on February 24, 2020 disabling the Auto Bladder Volume Tool from affected devices operating software versions 1.13.0, 1.14.0 and 1.15.0 for all affected US Butterfly iQ customers and removed references of Auto Bladder Volume Tool from outward marketing platforms. Butterfly Network has notified Affiliate partners to cease marketing the Auto Bladder Volume Tool until further notice. Questions related to this correction can be sent to Butterfly Network Customer Support via email at [email protected]
US Nationwide distribution.
15,121 host devices