CR DX-S, DX-S, Computed radiography system (Digitizer)
FDA device recall Z-0855-06 · posted 2006-05-09 · Terminated
Recall details
- Recalling firm
- AGFA Corp.
- Reason for recall
- Corrupted image after system start; Corrupted image after workflow interruption; An erasure unit problem can cause system to stop.
- Action taken
- Consignees were notified at the time of upgrading. The software was upgraded on 11/3/2005, 12/19/2005 and 12/28/2005. A Mandatory Service Bulletin, No. 11, explaining the issues was shared with the accounts.
- Root cause
- Other
- Status
- Terminated
- Product code
- MQB
- Quantity affected
- 3 units
- Distribution
- DC, MS, OR--three states
- Date initiated
- 2005-11-03
- Date posted
- 2006-05-09
- Date terminated
- 2006-06-20
- 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 |