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.

GE Medical Systems, LLC Medical Device Recall: Senographe Pristina, Pristina Serena, and Pristina Serena 3D. for screening and diagnostic mammography | SafeCheck