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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 Recall
Vantage Titan 3T MRI System, MRT3010A/5
see related information
Date Posted November 13, 2013
Recall Status1 Open
Recall Number Z-0201-2014
Recall Event ID 66725
Premarket Notification
510(K) Number
K102489 
Product Classification System, Nuclear Magnetic Resonance Imaging - Product Code LNH
Product Titan 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, California 92780-7047
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
COMPONENT CONTROLS (GMP - GOOD MANUFACTURING PRACTICE): Nonconforming Material/Component
Action Toshiba 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 Commerce 18 units
Distribution USA Nationwide Distribution in the states of: CA, FL, GA, IA, NV, NY, LA, IN, PA, OR, TX, and WI.
Total Product Life Cycle TPLC Device Report

 
1 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
510(K) Database 510(K)s with Product Code = LNH and Original Applicant = TOSHIBA MEDICAL SYSTEMS CORPORATION, JAPAN
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