Toshiba Digital Radiography System Model DFP8000D
FDA device recall Z-0532-06 · posted 2006-02-23 · Terminated
Recall details
- Recalling firm
- Toshiba American Med Sys Inc
- Reason for recall
- In certain conditions the FOV of the lateral plane does not coincide with the X-ray exposed area, and consequently a part of the X-ray field may not be displayed in the magnification mode.
- Action taken
- An Advisory Letter will be sent to customers via certified mail. Corrected software will be provided at no charge. Customers can contact their local Toshiba Service person to schedule the software update.
- Root cause
- Other
- Status
- Terminated
- Product code
- JAA
- Quantity affected
- 3
- Distribution
- CO, MI, & TX
- Date initiated
- 2005-11-15
- Date posted
- 2006-02-23
- Date terminated
- 2007-07-12
- 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 |
|---|---|---|
| DIGITAL RADIOGRAPHY SYSTEM, MODEL DFP-8000D (K013608) | Toshiba America Medical Systems, In.C | 2001-11-15 |