Recall Z-1101-2013 ยท LNH System, Nuclear Magnetic Resonance Imaging
Toshiba American Medical Systems Inc
MRT-1504/A4 - Titan X MRI System MRT-30 I0A/5 - Titan 3T MRI System Product Usage: MRI System.
| Date | Apr 11, 2013 (initiated Oct 15, 2012) |
| Status | Terminated |
| 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 |
| Root cause | Nonconforming Material/Component |
| 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. |
| 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. |
| FDA record | Open on fda.gov |