Recall Z-2315-2012 ยท LNH System, Nuclear Magnetic Resonance Imaging
Toshiba American Medical Systems Inc
Toshiba Ultra-Short Magnetic Resonance Imaging System, EXCELART Vantage. MRT-1503/P5-Vantage MRI System. MR imaging.
| Date | Sep 6, 2012 (initiated Feb 21, 2012) |
| Status | Terminated |
| Reason | The firm recalled due to a potentail problem with the position of the hold in the lug teminals on the power cables connected to the terminal blocks on the gradient coil. |
| Root cause | Component change control |
| Action | Toshiba America Medical Systems, Inc, sent a Urgent Medical Device Correction letter dated February 21, 2012, via USPS return receipt mail to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. Customers were instructed if you subsequently find that images are abnormally noisy compared to images acquired under the same conditions in the system before this modification was performed, contact your Toshiba Service Representative. Please share this information with all users and reviewing radiologist as well as clinical en |
| Quantity | 3 units |
| Distribution | US (nationwide) distribution including the states of Ohio and Texas. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K060003 | EXCELART VANTAGE ZGV Toshibamedical Systems Corporation, Jan 18, 2006 |