Home / Recalls / Butterfly Network, Inc. / Z-1600-2020

Z-1600-2020 Class II Terminated

Recalled by Butterfly Network, Inc. — Guilford, CT

FDA device recall Z-1600-2020 was initiated by Butterfly Network, Inc. on February 24, 2020 and is designated Class II. Reason for recall: Distributed without an approved 510(k) The recall status is terminated (terminated June 12, 2020). Affected quantity: 15,121 host devices.

Recall Details

Product Type: Devices
Report Date: April 8, 2020
Initiation Date: February 24, 2020
Termination Date: June 12, 2020
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 15,121 host devices

Product Description

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 Pattern

US Nationwide distribution.

Code Information

Software versions 1.13.0, 1.14.0, and 1.15.0 UDI: (01)00866646000206