GE Medical Systems, LLC recalls Senographe Pristina

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).

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.

• FDA enforcement recordOfficial FDA database entry for Z-0875-2026
• FDA 510(k) clearance · K162268The device's official FDA premarket clearance record
• FDA 510(k) clearance · K173576The device's official FDA premarket clearance record
• FDA 510(k) clearance · K182951The device's official FDA premarket clearance record
• FDA device classification · MUEOfficial FDA classification for this device type
• CFR regulation · 21 CFR 892.1715The federal regulation governing this device
• FDA recall announcementSearch FDA.gov for the official press announcement
• Find GE Medical Systems, LLCSearch for the manufacturer's official notice
• News coverageRecent reporting on this recall and manufacturer
• openFDA data recordThe raw JSON record this page is built from

Source: U.S. FDA openFDA device enforcement reports. This summary is informational and may lag or differ from the official record. Always verify against the FDA before acting.