Recall Z-0875-2026— GE Medical Systems, LLC

Name: FDA recall Z-0875-2026
Creator: U.S. Food and Drug Administration
Published: 2025-10-24

Class II · Ongoing

Class II FDA medical device recall by GE Medical Systems, LLC, initiated 2025-10-24. It names 3 FDA 510(k) clearances: K182951, K173576, K162268. Product: Senographe Pristina, Pristina Serena, and Pristina Serena 3D. for screening and diagnostic mammography. Reason: 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)..

Recalling firm: GE Medical Systems, LLC
Classification: Class II
Status: Ongoing
Initiated: 2025-10-24
Firm location: Waukesha, WI, United States

510(k) clearances named in this recall

3 on FDA's record

K182951 — Pristina Serena 3DGE Healthcare·cleared 2019-01-18
K173576 — Pristina SerenaGE Healthcare·cleared 2018-05-14
K162268 — Senographe PristinaGE Healthcare·cleared 2016-11-03

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

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

Reason for recall

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).

Data sourced from openFDA. This site is unofficial and independent of the FDA.