GE Medical Systems, LLC recalls Senographe Pristina, Pristina Serena, and Pristina Serena 3D. for screening and diagnostic mammography

Recall date

October 24, 2025

Source

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

Recall number

Z-0875-2026

FDA classification

Class II

Brand / firm

GE Medical Systems, LLC

Sold / distributed

U.S. and OUS.

Why it was recalled

Some Senographe Pristina systems either have a missing or an incorrect X-Ray Warning label, which is a nonconformance to FDA Regulation 21 CFR ¿1020.30(j).

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

What was recalled

Senographe Pristina, Pristina Serena, and Pristina Serena 3D. for screening and diagnostic mammography