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

FDA device recall Z-0875-2026 · posted 2025-12-09 · Open, Classified

Recall details

Recalling firm: GE Medical Systems, LLC
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).
Action taken: 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
Status: Open, Classified
Product code: MUE
Quantity affected: 1,818 (1,580 US; 238 OUS)
Distribution: U.S. and OUS.
Date initiated: 2025-10-24
Date posted: 2025-12-09
Location: Waukesha, WI

Recalls and clearances share one API, with change alerts when new recalls post.