Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
Innova 4100IQ Indicated for use in generating fluoroscopic images of Recalled by GE Healthcare, LLC Due to Loss of imaging - affected devices may experience...
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
Innova 4100IQ Indicated for use in generating fluoroscopic images of human anatomy for vascular angiography, diagnostic and Interventional procedures and optionally, rotational imaging procedure.
Quantity: 6 (1 US, 5 OUS)
Why Was This Recalled?
Loss of imaging - affected devices may experience a loss of real-time interventional imaging and/or gantry motion due to the Electromagnetic (EM) sensitivity of the grid detection mechanism.
Where Was This Sold?
This product was distributed to 5 states: CA, CO, FL, MO, PA
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