IMPAX 4.5 Systems, used in the acceptance, transfer, display, storage and digital processing of medical images.
FDA device recall Z-1256-06 · posted 2006-07-27 · Terminated
Recall details
- Recalling firm
- AGFA Corp.
- Reason for recall
- Possible corrupted image appearing after System Start.
- Action taken
- On 06/30/2006 Agfa upgraded the Software on the installed units using a Mandatory Service Bulletin DD+DIS225.06E.
- Root cause
- Other
- Status
- Terminated
- Product code
- LLZ
- Quantity affected
- 2 units
- Distribution
- NY
- Date initiated
- 2006-06-30
- Date posted
- 2006-07-27
- Date terminated
- 2006-09-05
- 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 |