MRI System Displays Incorrect Field Gradient Safety Values
Canon Medical's Vantage Elan MRI system may display incorrect maximum Spatial Field Gradient values, potentially causing discomfort in patients with MR conditional devices.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This is a FDA Class II medical device recall with no reported illnesses or injuries. The hazard qualifies as risk-of-harm without reported injury—incorrect field gradient display values that may cause patient discomfort during MR scanning.
Plain-English summary
Canon Medical System, USA, INC. is recalling certain Vantage Elan MRI systems (Model MRT-2020) because the maximum Spatial Field Gradient (SFG) values displayed in the system's operation window and described in the safety manual are lower than the correct values.
These incorrect values may cause patients with MR conditional devices to experience discomfort during their MR scans. Patients and operators should be aware that the system may not be displaying accurate safety information for field gradient limits.
The affected systems were distributed nationwide and internationally. If you operate one of these MRI systems, contact Canon Medical or your equipment service representative to verify the correct SFG values and obtain corrective information or updates.
The recalled product
- Product
- MRI system: Vantage Elan, Model: MRT-2020
- Manufacturer
- Canon Medical System, USA, INC.
- Affected units
- 1
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- UDI-DI: 04987670101632. Serial Number: S1F2052753
Distribution
Part of a larger recall action
This product is one of 3 recalled by Canon Medical System, USA, INC. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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