IMPAX 6.5 Client Software. IMPAX 6.5 combines the traditional activities of RIS informatics management with PACS image m
FDA device recall Z-2246-2011 · posted 2011-05-24 · Terminated
Recall details
- Recalling firm
- AGFA Corp.
- Reason for recall
- Software issue that occurs after dictation of a study.
- Action taken
- Agfa Corp. sent an "URGENT SAFETY NOTICE" customer letter via Agfa email to customers on 4/14/2011, along with a "URGENT SAFETY NOTICE FEEDBACK FORM," The letter identified the product , the problem, and the action to be taken by the customer. It was discovered a software issue in the IMPAX 6.5. The upgrade has already been released to address the software problem. Customers were instructed to fax back the feedback form as soon as possible to (864) 421-1664. If you have any questions, please contact your local Agfa Healthcare organization.
- Root cause
- Other
- Status
- Terminated
- Product code
- LLZ
- Quantity affected
- 95 units
- Distribution
- Nationwide Distribution -- including states of WI, and SC.
- Date initiated
- 2011-04-05
- Date posted
- 2011-05-24
- Date terminated
- 2011-09-15
- 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 |