| Class 2 Device Recall MRI System | |
Date Initiated by Firm | October 15, 2012 |
Date Posted | April 11, 2013 |
Recall Status1 |
Terminated 3 on November 06, 2013 |
Recall Number | Z-1101-2013 |
Recall Event ID |
64670 |
510(K)Number | K113093 K120638 |
Product Classification |
System, nuclear magnetic resonance imaging - Product Code LNH
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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 CA 92780-7047
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For Additional Information Contact | 714-730-5000 |
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 | 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 |
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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.
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510(K) Database | 510(K)s with Product Code = LNH
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