Canon Medical System, USA, INC.: Medical Device Recall in 2024 - (Recall #: Z-1249-2024)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2024.

Data Source: FDA.

Product Description:

MRI system: Vantage Elan, Model: MRT-2020

Product Classification:

Class II

Date Initiated: January 29, 2024

Date Posted: March 13, 2024

Recall Number: Z-1249-2024

Event ID: 93874

Reason for Recall:

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.

Status: Ongoing

Product Quantity: 1

Code Information:

UDI-DI: 04987670101632. Serial Number: S1F2052753

Distribution Pattern:

Worldwide - US Nationwide distribution including in the states of MD, IL, WV, CA, AZ, PR, CO, GA, PA, WA, UT, OK, KY, IA, IN, TN, CT, WI, OH, AL, MT, NM, TX, MO, MN, OR, ID, WY, NV, AR, FL, SD, MI, NY, NJ, KS, LA, NH, VT, MS, SC, ME and the country of DO.

Voluntary or Mandated:

Voluntary: Firm initiated