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U.S. Department of Health and Human Services

Class 2 Device Recall MRI system

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 Class 2 Device Recall MRI systemsee related information
Date Initiated by FirmJanuary 29, 2024
Date PostedMarch 04, 2024
Recall Status1 Open3, Classified
Recall NumberZ-1250-2024
Recall Event ID 93874
510(K)NumberK122613 
Product Classification System, nuclear magnetic resonance imaging - Product Code LNH
ProductVantage Titan, Model: MRT-1504
Code Information UDI-DI: 04987670102400. Serial Numbers: U4B15Y2102, U5B15Z2001, U4B1492080, U4B1582100, U4B1582099, U4B1522091, U4B1512089, U4B1432067, U4B1522093, U4B1452073, U4B1442069, U4B1442068, U4B1642106, U4B1432066, U4B15X2101, U4B14Y2083, U4B1452071, U4B1512087, U4B1652107, U4B1552097, U4B1482078, U4B1512090, U4B1552098, U4B1442070, U4B14Y2082, U4B1482076, U4B14Z2085, U4B14Z2086, U4B1512088, U4B1612103, U4B1472075, U4B1422065, U4B1462074, U4B14Y2084, U4B1632105, U4B1452072, U4B1492081, U4B1482079, U4B1612104, U4B1482077
Recalling Firm/
Manufacturer		 Canon Medical System, USA, INC.
2441 Michelle Dr
Tustin CA 92780-7047
For Additional Information Contact
714-730-5000
Manufacturer Reason
for Recall		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.
FDA Determined
Cause 2		Component change control
ActionOn 01/29/24, correction notices were emailed to customers who were informed the following: The parts required to address the issue are expected to be available no earlier than February 2024. Until the countermeasure is performed, please use the values shown in the table shown in the correction notice. Share the contents of this letter with all users and reviewing radiologist as well as clinical engineering or biomedical group at your facility. If you have any questions regarding this letter please contact Regulatory Affairs at 800-421-1968 or your Canon service representative at 800-521-1968.
Quantity in Commerce40
DistributionWorldwide - US Nationwide distribution including in the states of MD, IL, WV, CA, AZ, PR, CO, GA, PA, WA, UT, OK, KY, IA, IN, TN, CT, WI, OH, AL, MT, NM, TX, MO, MN, OR, ID, WY, NV, AR, FL, SD, MI, NY, NJ, KS, LA, NH, VT, MS, SC, ME and the country of DO.
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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