Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
MRI system: Vantage Orian Recalled by Canon Medical System, USA, INC. Due to For some MRI systems, it has been found...
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
MRI system: Vantage Orian, Vantage Fortian, Model: MRT-1550
Quantity: 118
Why Was This Recalled?
For some MRI systems, it has been found that some of the maximum Spatial Field Gradient (SFG) values displayed in "System Information" of the operation window and some of the maximum SFG values described in the safety manual are lower than the correct values, which may cause a patient with an MR conditional device to feel some discomfort during the MR scan.
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