CR DX-S, Image Intensified Fluoroscopic X-ray system.
FDA device recall Z-0031-2007 · posted 2006-10-12 · Terminated
Recall details
- Recalling firm
- AGFA Corp.
- Reason for recall
- Three separate issues involving the Agfa DX-S CR System, were detected that could lead to an image loss.
- Action taken
- Consignees were notified by letter on/about 06/28/2006.
- Root cause
- Other
- Status
- Terminated
- Product code
- MQB
- Quantity affected
- 11 units
- Distribution
- CA, DC, FL, MN, MI, MS, OR.
- Date initiated
- 2006-06-28
- Date posted
- 2006-10-12
- Date terminated
- 2007-05-10
- Location
- Greenville, SC
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| AGFA CR50.0 (K050810) | Agfa Corp. | 2005-04-21 |