Use caution Medical device recall · FDA · Published May 30, 2018

Canon Medical MRI Systems Recall: SAR Display May Underestimate Radiation Levels

Canon Medical recalls specific MRI systems (MEXL-1504 and MEXL-1510/MEXL-1520 models) where SAR values may be displayed lower than actual radiation levels during respiratory gating with Steady Mode ON in Spin Echo sequences.

Plain-English summary generated from official FDA data by GovInfoNow · Published by Carlos Caban · How we make summaries

🇺🇸 FDA recall #Z-0199-2019Medical device Canon Medical ›

Use caution until it’s fixed

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.

Take action

Contact the company

Recalling firmCanon Medical System, USA, INC.2441 Michelle Dr · Tustin, CA 92780-7047

✎ GovInfoNow plain-language explainer

Canon Medical is recalling certain MRI systems that may display lower radiation levels than actually applied when using respiratory gating with Steady Mode ON in Spin Echo sequences. This could potentially exceed safety limits for radiation exposure during imaging procedures. Read more at govinfonow.com/recall/70934-canon-medical-mri-systems-recall-sar-display-may-underestimate-radiation.

Source Summary by GovInfoNow · govinfonow.com/recall/70934-canon-medical-mri-systems-recall-sar-display-may-underestimate-radiation · Updated August 21, 2026 · FDA enforcement record: FDA #Z-0199-2019

Cite this page

“Canon Medical MRI Systems Recall: SAR Display May Underestimate Radiation Levels.” GovInfoNow, updated August 21, 2026. https://govinfonow.com/recall/70934-canon-medical-mri-systems-recall-sar-display-may-underestimate-radiation. Based on FDA recall #Z-0199-2019 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0199-2019%22&limit=1).

The FDA announced on May 30, 2018, that Canon Medical System, USA, INC. is recalling Nuclear Magnetic Resonance Imaging Systems because the displayed Specific Absorption Rate may be lower than the actual value, potentially exceeding safety limits. The agency classified this as a Class II recall.

How to tell if you have it

Brand: Canon Medical
Model MEXL-1504 with serial numbers including U4A12Z2020 (30005914), S4D1132069 (339325), and others listed in the record
Model MEXL-1510 with serial numbers including S2B1642037, S2A15Y2019, and others listed in the record
Model MEXL-1520 with serial numbers including S1C1672334 (30032698), S1C1682336 (30035150), and others listed in the record
Units affected: 252

The hazard

When using respiratory gating with Steady Mode ON in Spin Echo sequence scanning, the SAR 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.

Context

GovInfoNow's records show Canon Medical System, USA, INC. has 27 other recalls on record since April 18, 2018. Recent similar recalls include a Philips Brilliance CT 64 Medical Scanner recall dated August 7, 2026, and an AGFA DR 800 X-Ray System recall dated November 18, 2025.

How to tell if you have this one

Check for the model numbers MEXL-1504, MEXL-1510, or MEXL-1520 with the serial numbers listed in the recall notice. The systems are used for diagnostic imaging of head and body structures.

Brand
Canon Medical
Category
Medical device

Based on the official FDA remedy

What to do — step by step

Check System Settings
Verify if respiratory gating is used with Steady Mode ON in Spin Echo sequences before proceeding with scans.
Monitor SAR Values
Ensure the displayed SAR value does not exceed the first level controlled operating mode limits during imaging procedures.

Where it went and when

Where it was distributed

Distributed in 41 states, and outside the U.S.

FDA distribution: “Domestic: AL, AR, AZ, CA, CO, CT, FL, GA, IA, ID, IL, IN, KS, LA, MA, MD, MI, MN, MO, MS, MT, NC, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, SD, TN, TX, UT, VT, WA, WI, WV, and WY. International: Algeria, Australia, Bangladesh, Brazil,…” States read from FDA’s own wording; “not listed” means the notice does not name it.

States: Alabama, Arizona, Arkansas, California, Colorado, Connecticut, Florida, Georgia, Idaho, Illinois, Indiana, Iowa, Kansas, Louisiana, Maryland, Massachusetts, Michigan, Minnesota, Mississippi, Missouri, Montana, Nevada, New Hampshire, New Jersey, New Mexico, New York, North Carolina, Ohio, Oklahoma, Oregon, Pennsylvania, South Carolina, South Dakota, Tennessee, Texas, Utah, Vermont, Washington, West Virginia, Wisconsin, Wyoming.

Recall timeline

FDA published this recall 5 months after the firm started it.

May 30, 2018Firm started the recall
Oct 22, 2018FDA classified it Class II
Oct 31, 2018Published in FDA’s Enforcement Report

Dates from the agency record only; steps without a date are left out.

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Keep exploring

More Canon Medical recalls

Link to this recall

<a href="https://govinfonow.com/recall/70934-canon-medical-mri-systems-recall-sar-display-may-underestimate-radiation">Canon Medical MRI Systems Recall: SAR Display May Underestimate Radiation Levels (GovInfoNow)</a>

Where this comes from

The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.

Official source: FDA Recall #Z-0199-2019 (May 30, 2018) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0199-2019 to see it in context.
Plain-language summary written by qwen3:4b on August 21, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.