Excelart (tm) VANTAGE P2 & P3, Magnetic Resonance Imaging System,
FDA device recall Z-0061-05 · posted 2004-11-02 · Terminated
Recall details
- Recalling firm
- Toshiba American Med Sys Inc
- Reason for recall
- Scanned images are acquired at a position that is shifted relative to the intended position in the slice direction due to a software anomaly.
- Action taken
- Firm issued a letter to users on 9/29/2004 which includes a method to avoid the software problem until it can be corrected by an update.
- Root cause
- Other
- Status
- Terminated
- Product code
- LNH
- Quantity affected
- 22
- Distribution
- PA, MD, FL, OH, NY, CA, AR, KY, OK, AZ, TX, NV, IN.
- Date initiated
- 2004-09-16
- Date posted
- 2004-11-02
- Date terminated
- 2005-07-13
- 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 |