Official recall record
MRI system: Vantage Elan, Model: MRT-2020
- Issuing authority
- US FDA — Medical Devices
- Alert date
- 2024-01-29
- Country of alert
- United States
- Alert level
- Class II
- Alert type
- recall
- Barcode (EAN/GTIN)
- 04987670101632
- Brand on record
- Canon Medical System, USA, INC.
What the authority reported
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.
What to do
Follow the instructions in the official notice — recall remedies (refund, repair, replacement, or disposal) are defined by the issuing authority and the responsible business, and they differ per recall. Do not rely on summaries, including this one.
Verify at the source:
US FDA — Medical Devices — official record →
Record last checked against the registry on 2026-05-31.
Record last checked against the registry on 2026-05-31.
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VANTAGE GALAN 3T Model MRT-3020/MEXL-3020 - 2025-12-19 · US FDA — Medical Devices
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