FDA-Device2025-12-17Class IIMISBRANDING
GE Senographe Pristina mammography systems recalled for missing or incorrect X-ray warning label
LABEL MIX UPNationwide distribution
Check your GE Senographe Pristina mammography system
Some GE Senographe Pristina, Pristina Serena, and Pristina Serena 3D mammography systems were distributed with a missing or incorrect X-ray warning label. This label is required by federal regulation to inform users of radiation hazards. No injuries have been reported.
- Contact GE Medical Systems to verify your system's label is correct and complete
- Do not use the system if the X-ray warning label is missing or illegible until it is corrected
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).
Sold states
U.S. and OUS.
Affected count
1,818 (1,580 US; 238 OUS)
Manufactured in
3000 N Grandview Blvd, N/A, Waukesha, WI, United States
Products
Senographe Pristina, Pristina Serena, and Pristina Serena 3D. for screening and diagnostic mammography
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0875-2026More GE Medical Systems, LLC recalls
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- FDA-Device2026-06-17GE Allia IGS 7 Pulse X-ray system recalled for electrical shock risk to service personnel
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