FDA-Device2025-12-17Class II
Senographe Pristina, Pristina Serena, and Pristina Serena 3D. for screening and diagnostic mammography
GE Medical Systems, LLC
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-0875-2026Don't want to check this manually?
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