Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
Optima XR646 HD. X-Ray imaging system. Recalled by GE Medical Systems, LLC Due to The user can continue to take the next...
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
Optima XR646 HD. X-Ray imaging system.
Quantity: 3149 (1697 US; 1452 OUS)
Why Was This Recalled?
The user can continue to take the next exposure after reaching the Automatic Exposure Control (AEC) limit, without taking any further actions to acknowledge or adjust exposure techniques. In all cases, a message still appears on the screen when the AEC limit is reached.
Where Was This Sold?
This product was distributed nationwide across all 50 states.
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