Magnetic Resonance Imaging System Core Software, Software installed in all of the following: Flexart MRI System, Visart
FDA device recall Z-0937-04 · posted 2004-07-20 · Terminated
Recall details
- Recalling firm
- Toshiba American Med Sys Inc
- Reason for recall
- Software anomaly.
- Action taken
- Firm will send letters followed by visits to install software repair.
- Root cause
- Other
- Status
- Terminated
- Product code
- LNH
- Quantity affected
- 50
- Distribution
- Nationwide.
- Date initiated
- 2004-05-06
- Date posted
- 2004-07-20
- Date terminated
- 2005-03-15
- 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 |
|---|---|---|
| EXCELART WITH PIANISSIMO, MODEL MRT-1501/P3 (K002531) | Toshiba America Mri, Inc. | 2000-10-26 |
| EXCELART WITH PIANISSIMO (K993803) | Toshiba America Mri, Inc. | 2000-02-06 |
| EXCELART (K990620) | Toshiba America Mri, Inc. | 1999-05-14 |
| VISART (K961092) | Toshiba America Medical Systems, In.C | 1996-06-14 |
| MRT-50GP (K933018) | Toshiba America Mri, Inc. | 1994-02-18 |