Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
INFX-8000V. For radiographic and fluoroscopic studies and intervention. Recalled by Canon Medical System, USA, INC. Due to The fluoroscopic dose rate might exceed the conforming...
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 Canon Medical System, USA, INC. directly.
Affected Products
INFX-8000V. For radiographic and fluoroscopic studies and intervention.
Quantity: 16 systems
Why Was This Recalled?
The fluoroscopic dose rate might exceed the conforming value during biplane fluoroscopy.
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About Canon Medical System, USA, INC.
Canon Medical System, USA, INC. has 49 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report