Recall Z-1018-2026 ยท LNH System, Nuclear Magnetic Resonance Imaging
Canon Medical System, USA, INC.
VANTAGE TITAN 3T Model MRT-3010/MEXL-3010
| Date | Jan 13, 2026 (initiated Dec 19, 2025) |
| Status | Open, Classified |
| Reason | There is a potential for formation of ice occurring in the venting system of the superconducting magnet of the MRI systems. if a quench occurs in this condition, helium gas may not be able to escape via the designed vent paths, and the pressure in the helium vessel may rise. This pressure build-up could eventually rupture the helium vessel, causing helium gas to be released into the MR scanning room. |
| Root cause | Under Investigation by firm |
| Action | On 12/19/2025, the firm sent via Adobe DocuSign an "Urgent: Medical Device Correction" letter to customers informing them that It has been discovered that in the superconducting magnet used in the applicable system, if there is slow leakage, over a long period of time, of refrigerant gas from the superconducting magnet, air ingress into the helium vessel via the leak point may result in ice forming. If this is left unchecked, the worst-case scenario is that the helium gas will not be able to escape through the designed exhaust path, and the helium tank could eventually rupture, releasing heliu |
| Quantity | 22 systems |
| Distribution | U.S. Nationwide distribution in the states of CA, CO, FL, IA, IL, IN, KS, MD, MO, MT, NV, NY, OH, OR, PA, PR, TX, VA, and WI. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K191128 | Vantage Titan 3T, MRT-3010, V2.5 Canon Medical Systems Corporation, Jun 26, 2019 |