Product Wiki · Recalls · U.S. FDA — Device Enforcement

Recall Z-1101-2013 — MRT-1504/A4 - Titan X MRI System MRT-30 I0A/5 - Titan 3T MRI System Product Usage: MRI System.

U.S. FDA — Device Enforcement · United States · 2012-10-15 · Class II

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-1101-2013
Date of alert
2012-10-15
Country / jurisdiction
United States
Risk level
Class II
Risk type
recall
Brand
Toshiba American Medical Systems Inc
Product category
device
Product type
Devices
Reported risk: 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
Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

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