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U.S. Department of Health and Human Services

Class 2 Device Recall MRI System

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 Class 2 Recall
MRI System
see related information
Date Posted April 11, 2013
Recall Status1 Terminated on November 06, 2013
Recall Number Z-1101-2013
Recall Event ID 64670
Premarket Notification
510(K) Numbers
K113093  K120638 
Product Classification System, Nuclear Magnetic Resonance Imaging - Product Code LNH
Product MRT-1504/A4 - Titan X MRI System MRT-30 I0A/5 - Titan 3T MRI System Product Usage: MRI System.
Code Information Product Numbers: MRT-1504/A4, MRT-1504/S4, MRT-3010/A5, MZKT-UPKHE/S1. Serial Numbers unique to each consignee.
Recalling Firm/
Manufacturer
Toshiba American Medical Systems Inc
2441 Michelle Dr
P.O. Box 2068
Tustin, California 92780-7047
Manufacturer Reason
for Recall
It was found that there is a problem with the LCD monitor used in the console. The LCD monitor may become blank during use. Specifically, the backlight of the LCD monitor may turn off while the system is in use, causing the LCD monitor to become blank. However, the other parts of the system continue to operate normally, and the risk of a serious health hazard is therefore very low. The LCD Moni
FDA Determined
Cause 2
COMPONENT CONTROLS (GMP - GOOD MANUFACTURING PRACTICE): Nonconforming Material/Component
Action Toshiba sent an Urgent Medical Device Correction letter dated October 1, 2012 via USPS return receipt mail to all affected customers . The letter identified the affected product, problem and actions to be taken. The letter contains a return reply form that is to be faxed to TAMS for retention. For questions contact your local Toshiba representative at 800-521-1968.
Quantity in Commerce 27 units
Distribution USA Nationwide Distribution including the states of : IL, NH, MA, MI, MO, PR, NV, NM, MN, ID, NY, OH, NC, AZ, MS, LA, OR, PA, CA, and CT.
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
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