Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
GE Healthcare Optima CL323i Product Usage: The angiographic X-ray systems Recalled by GE Medical Systems, LLC Due to GE Healthcare has recently become aware of 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 Medical Systems, LLC directly.
Affected Products
GE Healthcare Optima CL323i Product Usage: The angiographic X-ray systems are indicated for use for patients from newborn to geriatric in generating fluoroscopic and rotational images of human anatomy for cardiovascular, vascular and non-vascular, diagnostic and interventional procedures. Additionally, with the OR table, the angiographic X-ray systems are indicated for use in generating fluoroscopic and rotational images of human anatomy for image-guided surgical procedures. The OR table is suitable for interventional and surgical procedures.
Quantity: 108
Why Was This Recalled?
GE Healthcare has recently become aware of a potential safety issue related to a non-recoverable loss of displayed imaging (loss of monitor video) involving Optima CL323i & Optima IGS 320 systems .
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