Recall Z-1249-2024— Canon Medical System, USA, INC.

Name: FDA recall Z-1249-2024
Creator: U.S. Food and Drug Administration
Published: 2024-01-29

Class II · Ongoing

Class II FDA medical device recall by Canon Medical System, USA, INC., initiated 2024-01-29. It names one FDA 510(k) clearance: K210164. 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..

Recalling firm: Canon Medical System, USA, INC.
Classification: Class II
Status: Ongoing
Initiated: 2024-01-29
Firm location: Tustin, CA, United States

510(k) clearances named in this recall

1 on FDA's record

K210164 — Vantage Elan 1.5T, MRT-2020, V6.0Canon Medical Systems Corporation·cleared 2021-03-10

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

MRI system: Vantage Elan, Model: MRT-2020

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.