Senographe Pristina, Pristina Serena, and Pristina Serena 3D. for screening and diagnostic mammo...
FDA Recall #Z-0875-2026 — Class II — October 24, 2025
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).
Recalling Firm
GE Medical Systems, LLC — Waukesha, WI
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Devices
Product Quantity
1,818 (1,580 US; 238 OUS)
Distribution
U.S. and OUS.
Code Information
GTINs: 00840682118460, 00840682142052, 00840682145879, 00195278022745, 00195278276971, 00195278661999, 00195278665379, 00195278914026
Status
Ongoing
Voluntary / Mandated
FDA Mandated