—#217584

Product

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

FDA product code: MUE — Full Field Digital, System, X-Ray, Mammographic
Device class: Class 2
Medical specialty: Radiology
510(k) numbers: K162268, K173576, K182951
Affected lot / code info: GTINs: 00840682118460, 00840682142052, 00840682145879, 00195278022745, 00195278276971, 00195278661999, 00195278665379, 00195278914026

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).

Root cause (FDA determination)

Radiation Control for Health and Safety Act

Action the firm took

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.

Recalling firm

Firm: GE Medical Systems, LLC
Address: 3000 N Grandview Blvd, Waukesha, Wisconsin 53188-1615

Distribution

Distribution pattern: U.S. and OUS.

Timeline

Recall initiated: 2025-10-24
Posted by FDA: 2025-12-09
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #217584. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.