Toshiba Excelart VANTAGE Model MRT-1503, Magnetic Resonance Imaging Systems, Regulation Number 21 CPR 892.1000, Regulato
FDA device recall Z-0281-06 · posted 2005-12-14 · Terminated
Recall details
- Recalling firm
- Toshiba American Med Sys Inc
- Reason for recall
- To correct a hardware problem of water leakage in the cooling system inside the ASGC, leading to the replacement of the gradient coil.
- Action taken
- Toshiba America Medical Systems, Inc., (TAMS) customer service engineers will hand deliver The Advisory Letter and monitor the system during their monthly preventive maintenance.
- Root cause
- Other
- Status
- Terminated
- Product code
- LNH
- Quantity affected
- 65
- Distribution
- Nationwide
- Date initiated
- 2005-10-12
- Date posted
- 2005-12-14
- Date terminated
- 2007-07-12
- Location
- Tustin, CA
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| TOSHIBA EXCELART VANTAGE XGV/AGV MRI DIAGNOSTIC SYSTEM, MODELS MRT-1503/P3 AND MRT-1503/P2 (K032490) | Toshiba America Medical Systems, In.C | 2003-08-21 |