Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
Senographe Pristina Recalled by GE Medical Systems, LLC Due to Some Senographe Pristina systems either have a missing...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact GE Medical Systems, LLC directly.
Affected Products
Senographe Pristina, Pristina Serena, and Pristina Serena 3D. for screening and diagnostic mammography
Quantity: 1,818 (1,580 US; 238 OUS)
Why Was This Recalled?
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).
Where Was This Sold?
U.S. and OUS.
About GE Medical Systems, LLC
GE Medical Systems, LLC has 146 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report