Class II

Medical Device Recall: Senographe Pristina, Pristina Serena, and Pristina Serena 3D. for screening and diagnostic mammography

GE Medical Systems, LLC · October 24, 2025

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).

Distribution

U.S. and OUS.

Quantity Affected

1,818 (1,580 US; 238 OUS)

Source: FDA (openFDA Device Enforcement)

Recall number: Z-0875-2026

Status: ongoing

SafeCheck provides drug interaction information from FDA-approved product labeling (openFDA). This is for informational purposes only and is not medical advice. Always consult your healthcare provider before making medication decisions.