Recall Z-0875-2026 ยท MUE Full Field Digital, System, X-Ray, Mammographic
GE Medical Systems, LLC
Senographe Pristina, Pristina Serena, and Pristina Serena 3D. for screening and diagnostic mammography
| Date | Dec 9, 2025 (initiated Oct 24, 2025) |
| Status | Open, Classified |
| Reason | 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). |
| Root cause | Radiation Control for Health and Safety Act |
| Action | GE Healthcare notified sent customers notification letter dated October 24, 2025 and instructed in the letter, the customer will inspect and identify systems that have a missing or incorrect label. |
| Quantity | 1,818 (1,580 US; 238 OUS) |
| Distribution | U.S. and OUS. |
| FDA record | Open on fda.gov |