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.
FDA Recall Z-1601-2020 · Posted 2020-03-17
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Recalling FirmButterfly Network, Inc.
Recall StatusTerminated
Product CodeIYN
Date Initiated2020-02-24
Date Terminated2020-06-12
Product Quantity11,183
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 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 [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.
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