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U.S. Department of Health and Human Services

Enforcement Report - Week of April 17, 2013

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Product Detail

Product Description MRT-1504/A4 - Titan X MRI System MRT-30 I0A/5 - Titan 3T MRI System Product Usage: MRI System.
Recall Number Z-1101-2013
Classification Class II
Code Info The majority ofthe letters are sent via USPS return receipt mail. The letter contains a return reply form that is to be faxed to TAMS for retention. After two weeks contact will be made with each nonresponding location and a copy ofthe letter will be faxed to that location and the fax receipt will serve as proof ofnotification.
Product Distributed Qty 27 units
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 Monitor will be replaced with a new monitor.

Event Detail

Event Id 64670
Product Type Devices
Status Ongoing
Recalling Firm Toshiba American Medical Systems Inc
City Tustin
State CA
Country US
Voluntary / Mandated Voluntary: Firm Initiated
Recall Initiation Date 2012-10-15
Initial Firm Notification of Consignee or Public Letter
Distribution Pattern 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.