Home / device / Z-0875-2026 Class II Reported 2025-12-17
Senographe Pristina, Pristina Serena, and Pristina Serena 3D. for screening and diagnostic mammography Recalled by 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).
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Recall Number Z-0875-2026
Classification Class II
Status Ongoing
Category device
Initiated 2025-10-24
Reported 2025-12-17
Distribution U.S. and OUS.
Code Info GTINs: 00840682118460, 00840682142052, 00840682145879, 00195278022745, 00195278276971, 00195278661999, 00195278665379, 00195278914026 Source: openFDA enforcement report. WhichRecall is not affiliated with the FDA. See our disclaimer .