TOSHIBA SUPERCONDUCTING MRI SYSTEM Vantage Titan
Model MRT-1504 · CANON INC. · DI 04987670102400
LNH — System, Nuclear Magnetic Resonance Imaging · Class II · 21 CFR 892.1000
UDILibrary device dossier · generated 2026-09-14 · sources: FDA GUDID, openFDA (recalls, MAUDE, 510(k)/PMA), FDA Data Dashboard (inspections, compliance actions), 510(k) summary documents.
Recall history (5)
| Initiated | Recall # | Class | Status | Reason | Link basis |
|---|---|---|---|---|---|
| 2024-05-10 | Z-2041-2024 | Class II | Open, Classified | 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. | code info di |
| 2024-01-29 | Z-1250-2024 | Class II | Open, Classified | 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. | code info di |
| 2021-05-21 | Z-2044-2021 | Class II | Open, Classified | The MRI system contains a component that does not meet the appropriate flame retardancy-rating which could result in smoke or fire. | k number procode |
| 2018-05-30 | Z-0199-2019 | Class II | Open, Classified | When using respiratory gating with Steady Mode ON in Spin Echo sequence scanning, the SAR (Specific Absorption Rate) value displayed on the console may be lower than the actual SAR value. The actual applied SAR values may exceed the FIRST LEVEL CONTROLLED OPERATING MODE. | k number procode |
| 2012-10-15 | Z-1101-2013 | Class II | Terminated | It was found that there is a problem with the LCD monitor used in the console. The LCD monitor may become blank during use. Specifically, the backlight of the LCD monitor may turn off while the system is in use, causing the LCD monitor to become blank. However, the other parts of the system continue to operate normally, and the risk of a serious health hazard is therefore very low. The LCD Moni | k number procode |
Adverse-event reports — MAUDE (0)
Caveat (required reading): MAUDE report counts cannot be used to compute incidence rates or compare device safety. Reporting is incomplete, duplicated, and spikes with publicity; there is no denominator of devices in use. The peer line is a reporting baseline (average device in the same product code), not a risk measure.
| Month | This device (reports) | Product-code average (reports per device) |
|---|---|---|
| 2019-02 | 0 | 1 |
| 2019-03 | 0 | 2.5 |
| 2019-04 | 0 | 2.75 |
| 2019-05 | 0 | 1 |
| 2019-06 | 0 | 1 |
| 2019-07 | 0 | 2 |
| 2019-10 | 0 | 1.4 |
| 2019-11 | 0 | 1 |
| 2019-12 | 0 | 1 |
| 2020-02 | 0 | 1 |
| 2020-03 | 0 | 1 |
| 2020-07 | 0 | 1.6 |
| 2020-08 | 0 | 4 |
| 2020-09 | 0 | 1 |
| 2020-10 | 0 | 1 |
| 2020-12 | 0 | 1.5 |
| 2021-01 | 0 | 1 |
| 2021-02 | 0 | 1 |
| 2021-03 | 0 | 1 |
| 2021-05 | 0 | 1 |
| 2021-07 | 0 | 1 |
| 2021-08 | 0 | 1 |
| 2021-09 | 0 | 1.33 |
| 2021-10 | 0 | 1.33 |
| 2021-11 | 0 | 1 |
| 2021-12 | 0 | 1 |
| 2022-01 | 0 | 1 |
| 2022-02 | 0 | 1.75 |
| 2022-03 | 0 | 1.13 |
| 2022-04 | 0 | 1 |
| 2022-05 | 0 | 1 |
| 2022-06 | 0 | 1.33 |
| 2022-07 | 0 | 1 |
| 2022-08 | 0 | 1 |
| 2022-09 | 0 | 1.25 |
| 2022-10 | 0 | 1.17 |
| 2022-11 | 0 | 1 |
| 2022-12 | 0 | 1.33 |
| 2023-01 | 0 | 1 |
| 2023-02 | 0 | 1.33 |
| 2023-03 | 0 | 2.9 |
| 2023-04 | 0 | 1.5 |
| 2023-05 | 0 | 1.9 |
| 2023-06 | 0 | 1.5 |
| 2023-07 | 0 | 1.38 |
| 2023-08 | 0 | 2.17 |
| 2023-09 | 0 | 2 |
| 2023-10 | 0 | 1.57 |
| 2023-11 | 0 | 2 |
| 2023-12 | 0 | 1.2 |
| 2024-01 | 0 | 1.2 |
| 2024-02 | 0 | 1 |
| 2024-03 | 0 | 1.33 |
| 2024-04 | 0 | 1.25 |
| 2024-05 | 0 | 1 |
| 2024-06 | 0 | 1 |
| 2024-07 | 0 | 1.33 |
| 2024-08 | 0 | 1.5 |
| 2024-09 | 0 | 1.17 |
| 2024-10 | 0 | 1.33 |
| 2024-11 | 0 | 1.78 |
| 2024-12 | 0 | 1.21 |
| 2025-01 | 0 | 4.86 |
| 2025-02 | 0 | 3.38 |
| 2025-03 | 0 | 2.36 |
| 2025-04 | 0 | 2 |
| 2025-05 | 0 | 2.35 |
| 2025-06 | 0 | 5 |
| 2025-07 | 0 | 5.64 |
| 2025-08 | 0 | 7.95 |
| 2025-09 | 0 | 4.53 |
| 2025-10 | 0 | 5.21 |
| 2025-11 | 0 | 4.11 |
| 2025-12 | 0 | 7.12 |
| 2026-01 | 0 | 5.95 |
| 2026-02 | 0 | 3.8 |
| 2026-03 | 0 | 3.48 |
| 2026-04 | 0 | 3.97 |
| 2026-05 | 0 | 6.61 |
| 2026-06 | 0 | 3.1 |
Regulatory clearances
- K122613 SESE 2012-12-13 (k number procode)
- K120638 SESE 2012-06-01 (k number procode)
- K112003 SESE 2011-12-02 (k number procode)
Predicate lineage
K112003 — cites (transitively): K080038 (d1) — cited as predicate by K120638
K120638 — cites (transitively): K050038 (d1), K080038 (d1), K112003 (d1) — cited as predicate by K122613, K141472, K150427
K122613 — cites (transitively): K120638 (d1), K050038 (d2), K080038 (d2), K112003 (d2)
Lineage extracted from public 510(k) summary text (heuristic).
Manufacturer compliance record — CANON INC.
- NAI 2014-09-19 Canon Components, Inc. (Factory Site) · 0 citations
- NAI 2014-09-17 Canon Inc. · 0 citations
- NAI 2014-09-17 Canon Inc. · 0 citations