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Terminated

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

FDA Recall Z-1101-2013 · Posted 2013-04-11

Recalling FirmToshiba American Medical Systems Inc
Recall StatusTerminated
Product CodeLNH
Date Initiated2012-10-15
Date Terminated2013-11-06
Product Quantity27 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 Moni

Firm 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.

Root Cause

Nonconforming Material/Component

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.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K120638VANTAGE TITANToshibamedical Systems Corporation · 2012-06-01K113093VANTAGE TITAN 3TToshibamedical Systems Corporation · 2012-01-13

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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