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GE Medical Systems, LLC recalls Senographe Pristina, Pristina Serena, and Pristina Serena 3D. for screening and diagnostic mammography
Recalled December 17, 2025 · FDA recall Z-0875-2026 · GE Medical Systems
Hazard
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). · FDA Class II
Units
1,818 (1,580 US; 238 OUS)
Sold at
U.S. and OUS.
Description
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).
Product
Senographe Pristina, Pristina Serena, and Pristina Serena 3D. for screening and diagnostic mammography
Manufacturer(s)
GE Medical Systems, LLC
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →