IMPAX 5.2 DB Server (running Oracle 10.1.0.4.0), medical imaging Picture Archiving and Communication System (PACS).
FDA device recall Z-0035-2014 · posted 2013-10-21 · Terminated
Recall details
- Recalling firm
- AGFA Corp.
- Reason for recall
- System downtime and/or slow performance may result if software in use is an old version of IMPAX and is not at current supported levels.
- Action taken
- An "URGENT FIELD SAFETY NOTICE" letter was sent via email to the consignees on 9/19/2013, Acknowledgement, via FAX-Back or email, that the information was received and understood has been requested from the consignees. The letter specifically describes the safety alert for the device, informs consignees of the problem and recommends the upgrades for IMPAX and Oracle.
- Root cause
- Software in the Use Environment
- Status
- Terminated
- Product code
- LLZ
- Quantity affected
- 4
- Distribution
- Worldwide distrbution: US(nationwide) distribution including NY and OK, and country of Canada.
- Date initiated
- 2013-09-19
- Date posted
- 2013-10-21
- Date terminated
- 2013-10-24
- 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 SE SIGMACOM CLIENT (PACS WORKSTATION) (K071297) | Agfa Healthcare Corp. | 2007-06-22 |