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Open, Classified

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

FDA Recall Z-0875-2026 · Posted 2025-12-09

Recalling FirmGE Medical Systems, LLC
Recall StatusOpen, Classified
Product CodeMUE
Date Initiated2025-10-24
Product Quantity1,818 (1,580 US; 238 OUS)

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).

Firm Action

GE Healthcare notified sent customers notification letter dated October 24, 2025 and instructed in the letter, the customer will inspect and identify systems that have a missing or incorrect label.

Root Cause

Radiation Control for Health and Safety Act

Distribution Pattern

U.S. and OUS.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K182951Pristina Serena 3DGE Healthcare · 2019-01-18K173576Pristina SerenaGE Healthcare · 2018-05-14K162268Senographe PristinaGE Healthcare · 2016-11-03

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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