Canon Medical recalls Vantage Titan MRI systems with model MRT-1504 due to incorrect Spatial Field Gradient values potentially causing patient discomfort during scans. Affected units have specific serial numbers.
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 Titan MRI systems with model MRT-1504 because some displayed and documented Spatial Field Gradient values are too low. This may cause discomfort for patients with MR conditional devices during scans. The recall affects specific units with listed serial numbers.
The MRI system displays incorrect maximum Spatial Field Gradient (SFG) values, which are critical for safe operation. These incorrect values may cause patients with MR conditional devices to feel discomfort during scans, but do not typically cause serious injury.
Patients using the Vantage Titan MRI system with model MRT-1504 and MR conditional devices may experience discomfort during scans. Those with the specific serial numbers listed in the recall are most at risk.
Check if your Vantage Titan MRI system has model number MRT-1504 and one of the listed serial numbers. The recall includes specific serial numbers starting with U4B, U4B15, U4B14, etc.
Identify if your Vantage Titan MRI system has model MRT-1504 and a serial number from the list provided in the recall.
The recall is due to incorrect maximum Spatial Field Gradient (SFG) values displayed in the system information and safety manual, which may cause discomfort for patients with MR conditional devices during scans.
No action is required if your system is not listed in the recall's serial numbers. The recall only affects specific units with the listed serial numbers.
The recall indicates a potential for patient discomfort during scans, but it does not typically cause serious injury. The hazard level is low risk.
We’ve drafted a message you can send Canon Medical to request your refund or repair — edit it as you like.
Subject: Recall Z-1250-2024 — Canon Medical Canon Medical Hello, I own a Canon Medical that is covered by recall Z-1250-2024 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.
