Computed Tomography, Models TSX-101A and TSX-021A.
FDA device recall Z-1031-04 · posted 2004-07-20 · Terminated
Recall details
- Recalling firm
- Toshiba American Med Sys Inc
- Reason for recall
- Erroneous patient data is entered. Previoius patient's demographics are recorded.
- Action taken
- Firm issued Field Modification Instruction which describes the action to be taken by the firm''s own service technicians. Recall letters were sent to each site informing of the issue and provide caution regarding the problem prior to it''s getting fixed.
- Root cause
- Software design
- Status
- Terminated
- Product code
- JAK
- Quantity affected
- 552
- Distribution
- Nationwide.
- Date initiated
- 2004-03-17
- Date posted
- 2004-07-20
- Date terminated
- 2011-11-01
- 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 |
|---|---|---|
| ASTEION CT SCANNER, TSX-021A (K982787) | Toshiba America Medical Systems, In.C | 1998-10-21 |
| AQUILION CT SCANNER, MODEL TSX-101A (K982265) | Toshiba America Medical Systems, In.C | 1998-08-26 |