Magnetic Resonance Imaging Systems under the following names: Visart Excelart Excelart P2 Excelart P3 Excelart SPIN Exce
FDA device recall Z-0270-05 · posted 2004-12-02 · Terminated
Recall details
- Recalling firm
- Toshiba American Med Sys Inc
- Reason for recall
- Software defect causes images to be rotated 180 degrees.
- Action taken
- Firm sent a letter to consignees October 6, 2004 describing the observed conditions causing the flaw to manifest itself. A workaround solution is also described in the letter. A software correction is under development and will be installed by a TAMS representative in the future.
- Root cause
- Other
- Status
- Terminated
- Product code
- LNH
- Quantity affected
- 67
- Distribution
- Nationwide
- Date initiated
- 2004-10-06
- Date posted
- 2004-12-02
- Date terminated
- 2005-09-02
- 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 XG/AG SPIN EDITION, MODEL MRT-1501/P3, P2 (K023511) | Toshiba America Medical Systems, In.C | 2002-11-05 |
| 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 |