Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
Optima XR220amx Mobile general purpose radiographic imaging of the human Recalled by GE Healthcare, LLC Due to Software issue: a violation of 21 CFR 1020.31(a)....
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
Optima XR220amx Mobile general purpose radiographic imaging of the human head and body.
Quantity: 254 total in the US
Why Was This Recalled?
Software issue: a violation of 21 CFR 1020.31(a). After an image is taken, when the user selects and clears an additionally displayed screen the system inhibit is also cleared, allowing the user to take an exposure without the technique factors being displayed.
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