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, SCS Due to X-ray exposure termination audible signal on Senographe Pristina...
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, SCS directly.
Affected Products
Senographe Pristina
Quantity: 180 units (60 US; 120 OUS)
Why Was This Recalled?
X-ray exposure termination audible signal on Senographe Pristina with Efficiency Suite 2 intermittently not emitted per 21CFR 1020.31(j) requirements.
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About GE Medical Systems, SCS
GE Medical Systems, SCS has 12 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report