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.
FDA Recall Z-1600-2020 · Posted 2020-03-17
Advertisement
Recalling FirmButterfly Network, Inc.
Recall StatusTerminated
Product CodeIYN
Date Initiated2020-02-24
Date Terminated2020-06-12
Product Quantity15,121 host devices
Reason for Recall
Distributed without an approved 510(k)
Firm 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 [email protected]
Root Cause
No Marketing Application
Distribution Pattern
US Nationwide distribution.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
Advertisement