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U.S. Department of Health and Human Services

Class 2 Device Recall Butterfly iQ

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  Class 2 Device Recall Butterfly iQ see related information
Date Initiated by Firm February 24, 2020
Date Posted March 17, 2020
Recall Status1 Open3, Classified
Recall Number Z-1601-2020
Recall Event ID 85178
510(K)Number K163510  
Product Classification System, imaging, pulsed doppler, ultrasonic - Product Code IYN
Product Butterfly iQ Ultrasound System containing the Auto EF(Ejection Fraction) Tool
REF/Model: 850-20003
UDI: (01)00866646000206
Software versions 1.10.0, 1.11.0, 1.12.0, 1.13.0, 1.13.0, 1.14.0, 1.15.0

Product Usage: Intended use: Diagnostic ultrasound imaging and measurement of anatomical structures.
Code Information Software versions 1.10.0 through 1.15.0
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 EF Tool from affected devices operating software versions 1.10.0 through 1.15.0 for all affected US Butterfly iQ users and removed references of the Auto EF Tool from outward marketing platforms. Butterfly Network has notified Affiliate partners to cease marketing the Auto EF 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 11,183
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 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
510(K) Database 510(K)s with Product Code = IYN and Original Applicant = BUTTERFLY NETWORK, INC.
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