IMPAX 5.2 Systems with CAD Capability (Computer Assisted Diagnosis)
FDA device recall Z-0033-2007 · posted 2006-10-12 · Terminated
Recall details
- Recalling firm
- AGFA Corp.
- Reason for recall
- Failed CAD displayed as 'No Findings'
- Action taken
- Consignees were notified by letter on/about 08/08/2006.
- Root cause
- Other
- Status
- Terminated
- Product code
- LLZ
- Quantity affected
- 20 Impax 5.2 Mammo licenses were issued domestically.
- Distribution
- Nationwide.
- Date initiated
- 2006-08-08
- Date posted
- 2006-10-12
- Date terminated
- 2007-02-20
- 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 |
|---|---|---|
| IMPAX DIAGNOSTIC DISPLAY STATION,IMPAX CLINICAL REVIEW STATION,IMPAX FOR CARDIOLOGY CLINICAL REVIEW SATATION,IMPAX ORTHO (K022292) | Agfa Corp. | 2002-09-12 |