MRI system: Vantage Elan, Model: MRT-2020
FDA Recall Z-1249-2024 · Posted 2024-03-04
Advertisement
Recalling FirmCanon Medical System, USA, INC.
Recall StatusOpen, Classified
Product CodeLNH
Date Initiated2024-01-29
Product Quantity1
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.
Firm 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.
Root Cause
Component change control
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.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
Advertisement