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U.S. Department of Health and Human Services

Class 2 Device Recall Vantage Titan 3T MRI System, MRT3010A/5

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 Class 2 Device Recall Vantage Titan 3T MRI System, MRT3010A/5see related information
Date Initiated by FirmOctober 28, 2013
Date PostedNovember 13, 2013
Recall Status1 Terminated 3 on December 24, 2014
Recall NumberZ-0201-2014
Recall Event ID 66725
510(K)NumberK102489 
Product Classification System, nuclear magnetic resonance imaging - Product Code LNH
ProductTitan 3T MRI System, MRT-3010A/5. Product Usage: Usage: MRI system.
Code Information Lot numbers not utilized. Serial Numbers:A5B1192003 A5B1192004, A5B11Y2005, A5B11Z2007, A5C1212008, A5C1212009, A5C1222010, A5C1232011, A5C1252012, A5C1262013, A5C1282014, A5C1292015, A5C12X2016, A5C12Y2017, A5C12Z2018, A5D1312019, A5D1322020, A5D1362021, XIB-A5A1082001, XIB-A5B11Y2006, A5D1372022, A5B1182002.
Recalling Firm/
Manufacturer		 Toshiba American Medical Systems Inc
2441 Michelle Dr
P.O. Box 2068
Tustin CA 92780-7047
For Additional Information Contact
714-730-5000
Manufacturer Reason
for Recall		Toshiba America Medical Systems, Inc. is recalling due to a potential problem with Specific Absorption Rate (SAR) values when using the Toshiba Titan 3T System. When the system is used in combination with either the QD Head Coil (MJQH-142A) or the Large Knee SPEEDER (MJAJ-182A), SAR values lower than the actual SAR values may be displayed on the operating monitor.
FDA Determined
Cause 2		Nonconforming Material/Component
ActionToshiba America Medical Systems, Inc. sent an "URGENT: MEDICAL DEVICE CORRECTION". letter dated October 28, 2013 via USPS return receipt mail. The letter contains a return reply form that is to be faxed to TAMS for retention. The letter listed Device, Serial Number, reason for recall, problem, corrective actions, request to customers, and contact information.
Quantity in Commerce18 units
DistributionUSA Nationwide Distribution in the states of: CA, FL, GA, IA, NV, NY, LA, IN, PA, OR, TX, 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 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database510(K)s with Product Code = LNH
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