Recall Z-2135-2016 ยท LNH System, Nuclear Magnetic Resonance Imaging
Toshiba American Medical Systems Inc
MEXL-3010/A5- Vantage Titan 3T Magnetic Resonance Imaging System Product Usage: Vantage Titan 3T (MRT-3010, M-Power V3.5) is an open-bore 3T MRI system that permits outstanding image quality without compromising on features or performance. Vantage Titan 3T combines the features of Atlas technology with Open-Bore technology, making patient comfort a priority. To offer an enhanced level of performa
| Date | Jul 6, 2016 (initiated Apr 14, 2016) |
| Status | Terminated |
| Reason | A potential problem associated to the gradient coil (ASGC) in the Titan 3T MRI System. |
| Root cause | Device Design |
| Action | An Urgent Medical Device Notification letter was sent to customers to alert them to a potential problem associated to the gradient coil (ASGC) in the Titan 3T MRI System. The letter informs the customers of the problem identify and the corrective action. Customers are informed that their Toshiba service representative will contact them for an appointment to install the modified software on their system when it becomes available. Customers are instructed to complete the attached customer response form and fax it to the toll-free number shown at the top of the form; sent via email to TAMS-Regu |
| Quantity | 33 units |
| Distribution | US Nationwide Distribution |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K152371 | Vantage Titan 3T Toshibamedical Systems Corporation, Oct 23, 2015 |