FDA Device recall Z-1249-2024
MRI system: Vantage Elan, Model: MRT-2020
- FDA Device
- Class II
- ongoing
- Published 2024-03-13
On 2024-03-13 the FDA classified a Class II recall of MRI system: Vantage Elan, Model: MRT-2020 by Canon Medical System Usa, citing 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 maxi….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1249-2024 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2024-01-29 |
| Published | 2024-03-13 |
| Last updated | 2026-09-13 11:57 UTC |
| Company | Canon Medical System Usa |
| Distribution | US |
Product
MRI system: Vantage Elan, Model: MRT-2020
Reason
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.
Identifiers
| code_info | UDI-DI: 04987670101632. Serial Number: S1F2052753 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:57 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1249-2024%22
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