Agfa Impax R6.3 DB Server. Impax Systems are Picture Archiving and Communication systems (PACs). PAC systems are used in
FDA device recall Z-1887-2009 · posted 2009-09-08 · Terminated
Recall details
- Recalling firm
- AGFA Corp.
- Reason for recall
- Measurements are inaccurate on multiple workstations.
- Action taken
- Agfa Healthcare issued an "URGENT FIELD SAFETY NOTICE" dated July 16, 2009. The notice informed of the problem and provided details to identify potentially compromised data that could result in measurement inaccuracies. A feedback form was provided to be completed and returned to the firm. For further information, contact Agfa Healthcare at 1-773-592-4769.
- Root cause
- Software design
- Status
- Terminated
- Product code
- LLZ
- Quantity affected
- One unit
- Distribution
- Nationwide Distribution -- IL
- Date initiated
- 2009-07-16
- Date posted
- 2009-09-08
- Date terminated
- 2011-04-28
- 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 |