Z-1249-2024Class II

MRI system: Vantage Elan, Model: MRT-2020

Name: Z-1249-2024 MRI system: Vantage Elan, Model: MRT-2020
Creator: Canon Medical System, USA, INC.
Published: 2024-01-29
License: https://open.fda.gov/license/

Canon Medical Systems USA, Inc. / initiated 2024-01-29 / Open, Classified

FDA source

Canon Medical System, USA, INC. began a recall of MRI system: Vantage Elan, Model: MRT-2020 on 2024-01-29. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Open, Classified.

Recall record

Recall number: Z-1249-2024
Classification: Class II
Status: Open, Classified
Initiated: 2024-01-29
Posted: 2024-03-04
Recalling firm: Canon Medical Systems USA, Inc.
Product: MRI system: Vantage Elan, Model: MRT-2020
Product code: LNH System, Nuclear Magnetic Resonance Imaging
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.
FDA root cause: Component change control
Action: On 01/29/24, correction notices were emailed to customers who were informed the following: The parts required to address the issue are expected to be available no earlier than February 2024. Until the countermeasure is performed, please use the values shown in the table shown in the correction notice. Share the contents of this letter with all users and reviewing radiologist as well as clinical engineering or biomedical group at your facility. If you have any questions regarding this letter please contact Regulatory Affairs at 800-421-1968 or your Canon service representative at 800-521-1968.
Quantity in commerce: 1
Distribution: 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.
Product codes and lots: UDI-DI: 04987670101632. Serial Number: S1F2052753

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1249-2024
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1248-2024	Class II	Ongoing	Voluntary: Firm initiated	2024-03-13	2024-03-04
Z-1249-2024	Class II	Ongoing	Voluntary: Firm initiated	2024-03-13	2024-03-04
Z-1250-2024	Class II	Ongoing	Voluntary: Firm initiated	2024-03-13	2024-03-04

Product code LNH

K210164Class IIVantage Elan 1.5T, MRT-2020, V6.0Canon Medical Systems Corporation / cleared 2021-03-10

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)