Digisonics, Inc recalls Digisonics OBView Versions 4.8.2 SP6 - 4.8.3, Ultrasound reporting software

Recall date

June 26, 2023

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-2214-2023

FDA classification

Class II

Brand / firm

Digisonics, Inc

Sold / distributed

US Distribution: AK, NH, WY, TX, NE, CA, MD, TX, OR IA, IL, MO, OR, NY, UT, PA, MA, GA, VA, WA, WI, and Internationally to :Aruba

Why it was recalled

Software issue

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

Digisonics OBView Versions 4.8.2 SP6 - 4.8.3, Ultrasound reporting software