Canon Medical recalls Vantage Elan MRI systems (Model MRT-2020) due to potential incorrect safety settings that may cause discomfort for patients with MR conditional devices during scans.
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 Vantage Elan MRI systems (Model MRT-2020) because some safety settings might be incorrect, which could cause discomfort for patients with MR conditional devices during scans. This recall does not involve immediate safety risks but requires attention to ensure patient comfort.
The MRI system displays incorrect maximum Spatial Field Gradient (SFG) values in its safety settings, which could lead to discomfort for patients with MR conditional devices during scans. This issue does not pose a risk of injury but may cause patient discomfort.
Patients using the Vantage Elan MRI system (Model MRT-2020) with MR conditional devices may experience discomfort during scans. Those most at risk are individuals with medical implants that are MR conditional.
Check for the Vantage Elan MRI system with Model MRT-2020. The serial number is S1F2052753 and the UDI-DI is 04987670101632.
Verify the maximum Spatial Field Gradient (SFG) values in the system's "System Information" window and safety manual to ensure they match the correct values.
No, the recall does not involve a risk of serious injury or death. The issue may cause discomfort for patients with MR conditional devices during scans but does not pose a safety hazard.
The recalled product is the Vantage Elan MRI system (Model MRT-2020) with serial number S1F2052753 and UDI-DI 04987670101632.
No, the recall does not require stopping use. However, checking the system settings for correct SFG values is recommended to ensure patient comfort.
We’ve drafted a message you can send Canon Medical to request your refund or repair — edit it as you like.
Subject: Recall Z-1249-2024 — Canon Medical Canon Medical Hello, I own a Canon Medical that is covered by recall Z-1249-2024 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.
Experiences, tips, and questions from readers. Every comment is reviewed before it appears.
No comments yet — be the first to share your experience.
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.
