Magnetic Resonance Imaging, System: Flexart, Visart and Excelart Models.
FDA device recall Z-0546-04 · posted 2004-07-20 · Terminated
Recall details
- Recalling firm
- Toshiba American Med Sys Inc
- Reason for recall
- Software anomally causes image slices to be in incorrect order.
- Action taken
- Firm sent letters to customers 1/28/2004 which explains how to avoid the adverse event and announces that a software fix is going to be made available.
- Root cause
- Other
- Status
- Terminated
- Product code
- LNH
- Quantity affected
- 24
- Distribution
- NV, CO, OH, PA, CA, TN, FL, TX, OK, OR, NY, NJ and Puerto Rico.
- Date initiated
- 2004-01-27
- Date posted
- 2004-07-20
- 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 |
|---|---|---|
| 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 |