Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
Nuclear Magnetic Resonance Imaging Systems that are indicated for use Recalled by Canon Medical System, USA, INC. Due to When using respiratory gating with Steady Mode ON...
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
Nuclear Magnetic Resonance Imaging Systems that are indicated for use as a diagnostic imaging modality that produces cross-sectional transaxial, coronal, sagittal, and oblique images that display anatomic structures of the head or body.
Quantity: 252
Why Was This Recalled?
When using respiratory gating with Steady Mode ON in Spin Echo sequence scanning, the SAR (Specific Absorption Rate) value displayed on the console may be lower than the actual SAR value. The actual applied SAR values may exceed the FIRST LEVEL CONTROLLED OPERATING MODE.
Where Was This Sold?
This product was distributed to 41 states: AL, AZ, AR, CA, CO, CT, FL, GA, ID, IL, IN, IA, KS, LA, MD, MA, MI, MN, MS, MO, MT, NV, NH, NJ, NM, NY, NC, OH, OK, OR, PA, SC, SD, TN, TX, UT, VT, WA, WV, WI, WY
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