Canon Medical recalls Vantage Orian and Vantage Fortian MRI systems (MRT-1550) due to incorrect spatial field gradient values potentially causing patient discomfort during scans. Affected units have specific serial numbers and UDI-DI codes.
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.
Canon Medical is recalling certain Vantage Orian and Vantage Fortian MRI systems (model MRT-1550) because some safety settings display incorrect values. This could cause discomfort for patients with MR conditional devices during scans. The recall affects specific units with listed serial numbers and UDI-DI codes.
The MRI systems display incorrect maximum Spatial Field Gradient (SFG) values in their safety settings. This could cause discomfort for patients who have medical devices that are MR conditional (approved for use in MRI scans) during the scanning process.
Patients using these MRI systems with MR conditional devices may experience discomfort during scans. The recall affects specific units with listed serial numbers and UDI-DI codes.
Check if your MRI system is a Vantage Orian or Vantage Fortian model with serial numbers listed in the recall notice or UDI-DI codes provided. The specific model is MRT-1550.
Look for the serial number on your MRI system's label or documentation to confirm if it's listed in the recall notice.
The recall is happening because some MRI systems display incorrect maximum Spatial Field Gradient (SFG) values, which could cause discomfort for patients with MR conditional devices during scans.
No, the recall does not require stopping use. The issue is about potential discomfort during scans, not immediate safety risks.
Check your serial number against the list of affected units provided in the recall notice or verify your UDI-DI code.
We’ve drafted a message you can send Canon Medical to request your refund or repair — edit it as you like.
Subject: Recall Z-1248-2024 — Canon Medical Canon Medical Hello, I own a Canon Medical that is covered by recall Z-1248-2024 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.
