Magnetic Resonance Imaging Systems; Visart, Excelart / Excelart P2 / Excelart P3 / Excelart SPIN & Excelart VANTAGE.
FDA device recall Z-0986-05 · posted 2005-07-13 · Terminated
Recall details
- Recalling firm
- Toshiba American Med Sys Inc
- Reason for recall
- Patient information A is displayed with images for patient B.
- Action taken
- Firm will have technicians correct each unit by visit. Instructions to them have issued.
- Root cause
- Other
- Status
- Terminated
- Product code
- LNH
- Quantity affected
- 102
- Distribution
- Nationwide.
- Date initiated
- 2005-05-25
- Date posted
- 2005-07-13
- Date terminated
- 2012-04-05
- 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 |