Magnetic Resonance Imaging System(s) Visart and Exelart P2/ Exelart P3/ Exelart SPIN and Exelart VANTAGE
FDA device recall Z-1045-04 · posted 2004-07-20 · Terminated
Recall details
- Recalling firm
- Toshiba American Med Sys Inc
- Reason for recall
- Wrong positioning may cause patient burns.
- Action taken
- An advisory letter will issue to all users May 26, 2004, with updated positioning information, and an employee will visit to make sure the letter was received and understood.
- Root cause
- Other
- Status
- Terminated
- Product code
- LNH
- Quantity affected
- 58
- Distribution
- Nationwide.
- Date initiated
- 2004-06-07
- Date posted
- 2004-07-20
- Date terminated
- 2005-01-04
- 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 |
|---|---|---|
| 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 (K990620) | Toshiba America Mri, Inc. | 1999-05-14 |
| VISART (K961092) | Toshiba America Medical Systems, In.C | 1996-06-14 |