| | Class 2 Device Recall VANTAGE GALAN 3T |  |
| Date Initiated by Firm | December 19, 2025 |
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| Date Posted | January 13, 2026 |
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| Recall Status1 |
Open3, Classified |
| Recall Number | Z-1017-2026 |
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| Recall Event ID |
98112 |
| 510(K)Number | K230355 |
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| Product Classification |
System, nuclear magnetic resonance imaging - Product Code LNH
|
| Product | VANTAGE GALAN 3T
Model MRT-3020/MEXL-3020 |
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| Code Information |
Model Number: MRT-3020/MEXL-3020
UDI-DI code: 04987670102615
CMSC Model Number/Model Number/Serial Numbers/SID/UDI code:
MRT-3020/4A MEXL-3020/5D 5DB2152002 30058153 (01)04987670102615(21)4AA2152001
MRT-3020/4A MEXL-3020/5D 5DC2262005 30075456 (01)04987670102615(21)4AB2262002
MRT-3020/4A MEXL-3020/5D 5DE2452007 30097122 (01)04987670102615(21)4AC2452003
MRT-3020/5A MEXL-3020/5D 5DB2172003 30047848 (01)04987670102615(21)5AA2172001
MRT-3020/6A MEXL-3020/7D 7DE2482014 30102813 (01)04987670102615(21)6AA2482002
MRT-3020/6A MEXL-3020/7D 7DE2472012 30108012 (01)04987670102615(21)6AA2472001
MRT-3020/7A MEXL-3020/7D 7DD2392008 30100563 (01)04987670102615(21)7AA2392001
MRT-3020/A4 MEXL-3020/D5 D5B2152013 30060527 (01)04987670102615(21)A4D2152004
MRT-3020/A4 MEXL-3020/D5 D5B2212019 30064817 (01)04987670102615(21)A4D2212006
MRT-3020/A4 MEXL-3020/D5 D5A2082005 30069306 (01)04987670102615(21)A4C2082002
MRT-3020/A4 MEXL-3020/D5 D5A2092007 30071480 (01)04987670102615(21)A4C2092003
MRT-3020/A4 MEXL-3020/D5 D5E24X2043 30072643 (01)04987670102615(21)A4F24X2010
MRT-3020/A4 MEXL-3020/D5 D5B2192016 30085151 (01)04987670102615(21)A4D2192005
MRT-3020/A4 MEXL-3020/D5 D5C2262022 30098384 (01)04987670102615(21)A4E2262008
MRT-3020/A4 MEXL-3020/D5 D5C2262021 30100803 (01)04987670102615(21)A4E2262007
MRT-3020/A4 MEXL-3020/D5 D5E2492042 30109383 (01)04987670102615(21)A4F2492009
MRT-3020/A5 MEXL-3020/S5 S5B18X2046 30007763 (01)04987670102615(21)A5B18X2011
MRT-3020/A5 MEXL-3020/S5 S5A17X2033 30031740 (01)04987670102615(21)A5A17X2008
MRT-3020/A5 MEXL-3020/S5 S5B17X2034 30034832 (01)04987670102615(21)A5B1882010
MRT-3020/A5 MEXL-3020/S5 S5A1732019 30036503 (01)04987670102615(21)A5A1732004
MRT-3020/A5 MEXL-3020/S5 S5A1742021 30040917 (01)04987670102615(21)A5A1742005
MRT-3020/A5 MEXL-3020/S5 S5C1972054 30041962 (01)04987670102615(21)A5C1972014
MRT-3020/A5 MEXL-3020/S5 S5A1732018 30042870 (01)04987670102615(21)A5A1732003
MRT-3020/A5 MEXL-3020/S5 S5B1842043 30043510 (01)04987670102615(21)A5B18X2012
MRT-3020/A5 MEXL-3020/D5 D5A2062003 30053897 (01)04987670102615(21)A5D2062015
MRT-3020/A5 MEXL-3020/S5 S5C18Y2048 30056987 (01)04987670102615(21)A5C18Y2013
MRT-3020/A5 MEXL-3020/D5 D5D23X2032 30087647 (01)04987670102615(21)A5G23X2017
MRT-3020/A5 MEXL-3020/D5 D5C2292024 30087649 (01)04987670102615(21)A5F2292016
MRT-3020/A5 MEXL-3020/S5.004 S5A1662001 30092401 (01)04987670102615(21)A5A1662001
MRT-3020/A6 MEXL-3020/D7 D7B2152015 30056208 (01)04987670102615(21)A6D2152001
MRT-3020/A7 MEXL-3020/S7 S7B1892004 30044596 (01)04987670102615(21)A7B1892001
MRT-3020/A7 MEXL-3020/D7 D7B2182017 30081608 (01)04987670102615(21)A7D2182004
MRT-3020/A7 MEXL-3020/S7.007 S7B1962013 30094084 (01)04987670102615(21)A7B1962002
MRT-3020/A7 MEXL-3020/S7.007 S7B1992017 30119571 (01)04987670102615(21)A7B1992003
MRT-3020/A7 MEXL-3020/S7 S7B1892004 30044596
MRT-3020/A7 MEXL-3020/D7 D7B2182017 30081608
MRT-3020/A7 MEXL-3020/S7.007 S7B1962013 30094084
MRT-3020/A7 MEXL-3020/S7.007 S7B1992017 30119571
|
Recalling Firm/
Manufacturer |
Canon Medical System, USA, INC.
2441 Michelle Dr
Tustin CA 92780-7047
|
| For Additional Information Contact | Orlando Tadeo
714-483-1551 |
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Manufacturer Reason
for Recall | 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. |
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FDA Determined
Cause 2 | Under Investigation by firm |
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| 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 helium gas into the MR scan room.
For safety management of the superconducting magnet, the status of the magnet is
checked during maintenance inspections and continuously monitored by a remote
monitoring system. However, in response to the above report from the manufacturer
of the superconducting magnet, an inspection to check for slow gas leaks in the
superconducting magnet used in systems installed at our customer sites will be
provided as a repair service. Note that there have been no reports of health hazards
related to this incident.
Customer are instructed to:
The system can continue to be used. However, please ensure there are adequate
evacuation routes from the scan/imaging room and the control room. Additionally, do
not press the quench button in cases other than emergencies.
A representative of Canon Medical Systems USA will contact you to schedule an
inspection. If you have any questions regarding this matter, please contact your service
representative.
Share the contents of letter with all users and reviewing radiologist as well as
clinical engineering or biomedical group at their facility. In addition, posted the Recall Letter on or near potentially affected systems.
For any questions regarding this letter please contact Orlando Tadeo, Director Regulatory Affairs, at 800-421-1968 or otadeo@us.medical.canon or your Canon service representative at 800-521-1968. |
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| Quantity in Commerce | 34 systems |
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| 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.
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| Total Product Life Cycle | TPLC Device Report |
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1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
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| 510(K) Database | 510(K)s with Product Code = LNH
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