Medical DeviceApr 8, 2020
Butterfly iQ Ultrasound System Auto Bladder Volume Tool-The Auto Bladder Volume Tool is a recall — FDA Z-1600-2020
Distributed without an approved 510(k)
Class IIFDA: TerminatedButterfly Network, Inc.
Recall history in this database
Classification mix: Class II: 2.
Medical DeviceApr 8, 2020
Butterfly iQ Ultrasound System containing the Auto EF(Ejection Fraction) Tool REF/Model recall — FDA Z-1601-2020
Distributed without an approved 510(k)
Class IIFDA: TerminatedButterfly Network, Inc.
Understanding this recall history
This page summarizes recall records in which the official source identifies Butterfly Network, Inc. as the recalling firm or manufacturer. The number of records should not be treated as a safety rating or a measure of company size, because recall counts depend on product mix, reporting periods and how government records are organized.
Compare the dates, categories and classifications together rather than relying on the total alone. Open an individual record for the recalled product, reason, distribution details and current instructions available from the source.