Device product
MRT-1504/A4 - Titan X MRI System MRT-30 I0A/5 - Titan 3T MRI System Product Usage: MRI System.
Z-1101-2013
Product summary
- Event
- Event 64670
- Status
- Terminated
- Classification
- Class II
- Quantity
- 27 units
- Official record key
device-enforcement:Z-1101-2013
Official wording
Reason: 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
Code information: Product Numbers: MRT-1504/A4, MRT-1504/S4, MRT-3010/A5, MZKT-UPKHE/S1. Serial Numbers unique to each consignee.
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.
Derived failure modes
-
Unknown
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