The Recall Desk
Agency classClass IIOur severity:ModerateFDA (Devices)·Z-1248-2024·Announced 2024-03-13

MRI Systems Show Incorrect Spatial Field Gradient Values

Canon Medical's MRI systems display incorrect Spatial Field Gradient values that are lower than actual, which may cause discomfort for patients with MR-conditional implanted devices during scanning.

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 2/5 (Moderate).

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: This FDA Class II recall involves documentation errors with no reported injuries or illnesses. The stated potential consequence is patient discomfort limited to a specific subset (those with MR-conditional devices), making this a labeling and documentation inaccuracy recalled as a precaution.

Plain-English summary

This recall affects Canon Medical's MRI systems, including the Vantage Orian, Vantage Fortian, and Model MRT-1550. A total of 118 systems are distributed nationwide across the United States, Puerto Rico, and the Dominican Republic.

The maximum Spatial Field Gradient (SFG) values displayed in the system's "System Information" section and described in the safety manual are lower than the actual correct values. These values are critical for ensuring safe operation of MR-conditional medical devices—implantable or wearable devices that must operate within specific magnetic field parameters.

Patients with MR-conditional devices who undergo MRI scans on affected systems may experience discomfort. Healthcare facilities should contact Canon Medical to obtain correct Spatial Field Gradient specifications and ensure operating procedures reflect accurate values before conducting MRI scans on patients with MR-conditional devices.

The recalled product

Product
MRI system: Vantage Orian, Vantage Fortian, Model: MRT-1550
Manufacturer
Canon Medical System, USA, INC.
Category
Medical Device — MRI Imaging System
Hazard
Affected units
118

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 (20)

  • UDI-DI: 04987670103360
  • 04987670104831. Serial Numbers: S2A1962005
  • S6B2312016
  • S2B2042009
  • S6B2262010
  • S4B2062020
  • S5B2292037
  • S2B2052011
  • S2B20Z2015
  • S6A20Z2001
  • SFA2372005
  • S5B2272031
  • S8B22X2013
  • S5B2122013
  • S8B2272009
  • S5B2172019
  • S2A1942004
  • S2C2252023
  • S2A18Z2001
  • S2A18Z2002

Distribution

Distributed nationwide across the United States.

The notice also names 42 states specifically:

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.

See all 3 products in this recall →

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