TOSHIBA SUPERCONDUCTING MRI SYSTEM Vantage Elan MRT-2020Recalls & reported problems

Summary

No MAUDE adverse event reports in our data reference this device identifier directly.

2 FDA recall records name this device's identifier, 2 still open.

1 other recall cover devices cleared under the same FDA submission (K141472, K171597, K210164); they may or may not involve this specific model.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Recalls naming this device

1. May 10, 2024Class IIOpen, Classified

   The terminal block used to secure the power supply cable for the gradient coil of the MRI system was not secured as designed, which could cause cable disconnection, which could lead to arcing, followed by melting of the cable, ignition, smoke, and fire.

   Z-2041-2024 · Root cause: Device Design · Recall details · FDA record ↗

2. Jan 29, 2024Class IIOpen, Classified

   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.

   Z-1249-2024 · Root cause: Component change control · Recall details · FDA record ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K141472, K171597, K210164. One submission often covers many models, so check the product and lot details in each record.

• Z-0199-2019 · May 30, 2018 · Open, Classified
  Nuclear Magnetic Resonance Imaging Systems that are indicated for use as a diagnostic imaging modality that produces cross-sectional transaxial, coronal, sagittal, and oblique imag