Recall Z-1600-2020 ยท IYN System, Imaging, Pulsed Doppler, Ultrasonic
Butterfly Network, Inc.
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 pediat
| Date | Mar 17, 2020 (initiated Feb 24, 2020) |
| Status | Terminated |
| Reason | Distributed without an approved 510(k) |
| Root cause | No Marketing Application |
| Action | 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 Support@butterflynetwork.com |
| Quantity | 15,121 host devices |
| Distribution | US Nationwide distribution. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K163510 | Poseidon Ultrasound System Butterfly Network, Inc., Sep 6, 2017 |