FDA recall Z-1601-2020

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.

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-1601-2020