CR QS (versions 3.0.207, 2.0.210 SU1, 3.0.229) ADC QS and Centricity CR Online Processing Software (version 2.x)
FDA device recall Z-0353-06 · posted 2006-01-06 · Terminated
Recall details
- Recalling firm
- AGFA Corp.
- Reason for recall
- Users of affected systems may experience one or more of four (4) problems the clinical impact could be a loss of image(s), the need to repeat the imaging procedure and, possibly, a short delay in diagnosis.
- Action taken
- Consignees will be notified by letter on/about December 1, 2005 and offered upgraded software.
- Root cause
- Other
- Status
- Terminated
- Product code
- LLZ
- Quantity affected
- 2630 units
- Distribution
- Nationwide
- Date initiated
- 2005-11-18
- Date posted
- 2006-01-06
- Date terminated
- 2009-06-30
- 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 |
|---|---|---|
| ADC QS/IPD WORKSTATION (K010571) | Agfa Corp. | 2001-03-28 |