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U.S. Department of Health and Human Services

Class 2 Device Recall VANTAGE TITAN 3T

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 Class 2 Device Recall VANTAGE TITAN 3Tsee related information
Date Initiated by FirmDecember 19, 2025
Date PostedJanuary 13, 2026
Recall Status1 Open3, Classified
Recall NumberZ-1018-2026
Recall Event ID 98112
510(K)NumberK191128 
Product Classification System, nuclear magnetic resonance imaging - Product Code LNH
ProductVANTAGE TITAN 3T Model MRT-3010/MEXL-3010
Code Information Model Number: MRT-3010/MEXL-3010 UDI-DI code: 04987670101649 CMSC Model Number/Model Number/Serial Numbers/SID/UDI code: MRT-3010/A5 MEXL-3010/A5 A5D14X2031 30000041 MRT-3010/A5 MEXL-3010/A5 A5D13Y2025 30001708 MRT-3010/A5 MEXL-3010/A5 A5D13Y2026 30005894 MRT-3010/A5 MEXL-3010/A5 A5G1692039 30007620 (01)04987670101649(21)A5G1692039 MRT-3010/A5 MEXL-3010/A5.007 A5B11Y2006 30019175 MRT-3010/A7 MEXL-3010/S7 S7A1642006 30024266 (01)04987670101649(21)A7A1642001 MRT-3010/A5 MEXL-3010/A5 A5G1692038 30027318 (01)04987670101649(21)A5G1692038 MRT-3010/A5 MEXL-3010/A5 A5G1642036 30029482 (01)04987670101649(21)A5G1642036 MRT-3010/A5 MEXL-3010/A5.007 A5F1562034 30050314 MRT-3010/A5 MEXL-3010/A5 A5B11Z2007 303354 MRT-3010/A5 MEXL-3010/A5 A5C1252012 336719 MRT-3010/A5 MEXL-3010/A5 A5D1312019 350553 MRT-3010/A5 MEXL-3010/A5 A5B1192003 350579 MRT-3010/A5 MEXL-3010/A5 A5C12X2016 350918 MRT-3010/A5 MEXL-3010/A5 A5C12Y2017 351122 MRT-3010/A5 MEXL-3010/A5 A5C1212009 351387 MRT-3010/A5 MEXL-3010/A5 A5B11Y2005 351452 MRT-3010/A5 MEXL-3010/A5 A5C1262013 356865 MRT-3010/A5 MEXL-3010/A5 A5C1292015 378015 MRT-3010/A5 MEXL-3010/A5 A5C1412028 383946 MRT-3010/A5 MEXL-3010/A5 A5E1522033 389630 MRT-3010/A5 MEXL-3010/A5 A5D1362021 390397
Recalling Firm/
Manufacturer		 Canon Medical System, USA, INC.
2441 Michelle Dr
Tustin CA 92780-7047
For Additional Information ContactOrlando Tadeo
714-483-1551
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.
FDA Determined
Cause 2		Under Investigation by firm
ActionOn 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.
Quantity in Commerce22 systems
DistributionU.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.
Total Product Life CycleTPLC Device Report
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.
510(K) Database510(K)s with Product Code = LNH
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