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.
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.
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.
When respiratory gating is used with Steady Mode ON in Spin Echo sequence scanning, the system may show a lower Specific Absorption Rate (SAR) value than the actual radiation level being applied. This could cause the radiation exposure to exceed the first level controlled operating mode safety limits.
Healthcare facilities using the recalled MRI systems (MEXL-1504, MEXL-1510, and MEXL-1520 models) are most at risk as these systems are used for medical imaging. Patients and staff may be exposed to higher radiation levels than indicated.
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.
Verify if respiratory gating is used with Steady Mode ON in Spin Echo sequences before proceeding with scans.
Ensure the displayed SAR value does not exceed the first level controlled operating mode limits during imaging procedures.
The recall affects Canon Medical MRI systems with model numbers MEXL-1504, MEXL-1510, and MEXL-1520, including specific serial numbers listed in the recall notice.
The recall indicates a potential risk of exceeding radiation safety limits during specific imaging procedures, but the official notice does not specify patient injury cases.
The official notice does not require immediate discontinuation of use; healthcare facilities should monitor SAR values during procedures.
We’ve drafted a message you can send Canon Medical to request your refund or repair — edit it as you like.
Subject: Recall Z-0199-2019 — Canon Medical Canon Medical Hello, I own a Canon Medical that is covered by recall Z-0199-2019 from Canon Medical. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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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.
