WhichRecall
Class IIReported 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.
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