|
Class 2 Device Recall Vantage Titan 3T MRI System, MRT3010A/5 |
|
Date Initiated by Firm |
October 28, 2013 |
Date Posted |
November 13, 2013 |
Recall Status1 |
Terminated 3 on December 24, 2014 |
Recall Number |
Z-0201-2014 |
Recall Event ID |
66725 |
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 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 |
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 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) Database |
510(K)s with Product Code = LNH and Original Applicant = TOSHIBA MEDICAL SYSTEMS CORPORATION, JAPAN
|
|
|
|