Recall Z-1248-2024 ยท LNH System, Nuclear Magnetic Resonance Imaging
Canon Medical System, USA, INC.
MRI system: Vantage Orian, Vantage Fortian, Model: MRT-1550
| Date | Mar 4, 2024 (initiated Jan 29, 2024) |
| Status | Open, Classified |
| 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. |
| 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 | 118 |
| 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K222968 | Vantage Fortian/Orian 1.5T, MRT-1550, V8.0 with AiCE Reconstruction Processing Unit for MR Canon Medical Systems Corporation, Oct 25, 2022 |