FDA recall Z-1600-2020

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.

Reason for recall

Distributed without an approved 510(k)

Distribution

US Nationwide distribution.

Key facts

Status

Terminated

Initiation date

2020-02-24

Report date

2020-04-08

Termination date

2020-06-12

Voluntary/Mandated

Voluntary: Firm initiated

Location

Guilford, CT, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1600-2020