Date Initiated by Firm |
February 24, 2020 |
Date Posted |
March 17, 2020 |
Recall Status1 |
Terminated 3 on June 12, 2020 |
Recall Number |
Z-1600-2020 |
Recall Event ID |
85185 |
510(K)Number |
K163510
|
Product Classification |
System, imaging, pulsed doppler, ultrasonic - Product Code IYN
|
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. |
Code Information |
Software versions 1.13.0, 1.14.0, and 1.15.0 UDI: (01)00866646000206 |
Recalling Firm/ Manufacturer |
Butterfly Network, Inc. 530 Old Whitfield St Guilford CT 06437-3441
|
Manufacturer Reason for Recall |
Distributed without an approved 510(k)
|
FDA Determined Cause 2 |
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 in Commerce |
15,121 host devices |
Distribution |
US Nationwide distribution. |
Total Product Life Cycle |
TPLC Device Report
|
|
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
|
510(K) Database |
510(K)s with Product Code = IYN and Original Applicant = BUTTERFLY NETWORK, INC.
|