Recall Z-2041-2024 ยท LNH System, Nuclear Magnetic Resonance Imaging
Canon Medical System, USA, INC.
MRI systems: Vantage Orian MRT-1550 (MEXL-1550), Vantage Elan MRT-2020 (MEXL-1520), Vantage Titan MRT-1504 (MEXL-1504), Vantage Titan 3T MRT-3010 (MEXL-3010), Vantage Galan 3T MRT-3020 (MEXL-3020)
| Date | Jun 9, 2024 (initiated May 10, 2024) |
| Status | Open, Classified |
| Reason | The terminal block used to secure the power supply cable for the gradient coil of the MRI system was not secured as designed, which could cause cable disconnection, which could lead to arcing, followed by melting of the cable, ignition, smoke, and fire. |
| Root cause | Device Design |
| Action | On 5/10/24, correction notices were sent to customers who were asked to do the following: 1) The replacement of the power cable securing parts that may cause smoke and fire, with parts made of materials with a higher degree of flame retardance, is now being released. 2) A firm representative will contact you to schedule a time to replace the power cable securing parts. 3) If any abnormalities such as unusual smells or smoke are observed before the work, immediately stop using the system and contact your service representative. 4) The parts required to address the defect are expected to be |
| Quantity | 153 |
| Distribution | US: PA, SC, IA, AL, MI, AR, SD, TX, ID, KY, NY, MN, MD, OH, WI, NV, CT, AZ, IL, OK, CA, FL, GA, OR, IN, NJ, CO, MT, KS, MO, WY, VA, VT, LA, NH, WV, TN, PR |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K122613 | VANTAGE TITAN WITH HELIOS GRADIENT MODEL MRT-1504/US Toshiba America Medical Systems, In.C, Dec 13, 2012 |
| K191128 | Vantage Titan 3T, MRT-3010, V2.5 Canon Medical Systems Corporation, Jun 26, 2019 |
| K210164 | Vantage Elan 1.5T, MRT-2020, V6.0 Canon Medical Systems Corporation, Mar 10, 2021 |
| K222968 | Vantage Fortian/Orian 1.5T, MRT-1550, V8.0 with AiCE Reconstruction Processing Unit for MR Canon Medical Systems Corporation, Oct 25, 2022 |
| K230355 | Vantage Galan 3T, MRT-3020, V9.0 with AiCE Reconstruction Processing Unit for MR Canon Medical Systems Corporation, Aug 30, 2023 |