EXCELART Vantage, Atlas, and Titan MRI Systems, MRT-1503 and MRT-1504. Imaging of the Whole Body, Fluid Visualization, 2
FDA device recall Z-2278-2012 · posted 2012-08-28 · Terminated
Recall details
- Recalling firm
- Toshiba American Medical Systems Inc
- Reason for recall
- The status display in the sequence queue window may not change from "Current" to "Done".
- Action taken
- A recall notification letter titled: "URGENT: MEDICAL DEVICE CORRECTION," was sent to customers. The letter stated the problem, corrective action, and (instructions) request to customers. Customers were instructed to perform the temporary recovery procedures if the problem occurs. Additionally, the acknowledgement sheet should be completed and faxed back. The information should be shared with all users, including the bio-medical or clinical engineering departments. Questions pertaining to the information for this recall were to be directed to (800) 421-1968.
- Root cause
- Process design
- Status
- Terminated
- Product code
- LNH
- Quantity affected
- 54
- Distribution
- Nationwide Distribution
- Date initiated
- 2008-05-13
- Date posted
- 2012-08-28
- Date terminated
- 2012-09-04
- 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 |
|---|---|---|
| VANTAGE TITAN, MODEL MRT-1504/S3 (K080038) | Toshiba America Medical Systems, In.C | 2008-01-22 |
| EXCELART VANTAGE ATLAS, MODEL MRT-1503 (K063361) | Toshiba America Medical Systems, In.C | 2006-11-21 |
| 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 |