FDAClass IIApril 17, 2013

MRT-1504/A4 - Titan X MRI System MRT-30 I0A/5 - Titan recall

MRT-1504/A4 - Titan X MRI System MRT-30 I0A/5 - Titan 3T MRI System Product Usage: MRI System.

Why was MRT-1504/A4 - Titan X MRI System MRT-30 I0A/5 - Titan recalled?

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

What should I do if I have this product?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

Product Numbers: MRT-1504/A4, MRT-1504/S4, MRT-3010/A5, MZKT-UPKHE/S1. Serial Numbers unique to each consignee.

Product
MRT-1504/A4 - Titan X MRI System MRT-30 I0A/5 - Titan 3T MRI System Product Usage: MRI System.
Recalling firm
Toshiba American Medical Systems Inc
Quantity
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.
Recall date
April 17, 2013
Classification
Class II
Status
Terminated
Agency
FDA (device)
Open FDA enforcement record Latest recalls