Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
GE Pristina Serena - Product Usage: Pristina Serena is an Recalled by GE Healthcare, LLC Due to Potential slippage of the biopsy positioner when the...
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 Healthcare, LLC directly.
Affected Products
GE Pristina Serena - Product Usage: Pristina Serena is an optional accessory of Senographe Pristina intended to provide accurate location of lesions in the breast in three dimensions.
Quantity: 16
Why Was This Recalled?
Potential slippage of the biopsy positioner when the gantry is rotated during a biopsy procedure.
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About GE Healthcare, LLC
GE Healthcare, LLC has 474 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report