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U.S. Department of Health and Human Services

Class 2 Device Recall ANTAGE GALAN 3T

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 Class 2 Device Recall ANTAGE GALAN 3Tsee related information
Date Initiated by FirmOctober 16, 2025
Date PostedOctober 24, 2025
Recall Status1 Open3, Classified
Recall NumberZ-0327-2026
Recall Event ID 97735
510(K)NumberK243335 
Product Classification System, nuclear magnetic resonance imaging - Product Code LNH
ProductVANTAGE GALAN 3T. CMSC Model: MRT-3020/U7. Model Number: MEXL-3020/B7.
Code Information CMSC Model: MRT-3020/U7. Model Number: MEXL-3020/B7. Serial Numbers: B7A2462002, B7A2522014.
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		Affected system contains components that do not meet the required distance between electrodes for compliance with the IEC 60601-1 standard for medical electrical equipment.
FDA Determined
Cause 2		Device Design
ActionCannon Medical began notifying consignees via email on about 10/16/2025. Consignees were instructed that a representative of Canon Medical Systems USA will contact them to schedule a time to replace the relevant parts. If the message "Gradient power supply error is displayed before the replacement is performed, immediately stop using the system and contact your service representative. Consignees were requested to complete and return the provided response form
Quantity in Commerce2 units
DistributionUS distribution to Ohio and Nevada
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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