Recall Z-0035-2014 ยท LLZ System, Image Processing, Radiological
AGFA Corp.
IMPAX 5.2 DB Server (running Oracle 10.1.0.4.0), medical imaging Picture Archiving and Communication System (PACS).
| Date | Oct 21, 2013 (initiated Sep 19, 2013) |
| Status | Terminated |
| Reason | 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. |
| Root cause | Software in the Use Environment |
| Action | 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. |
| Quantity | 4 |
| Distribution | Worldwide distrbution: US(nationwide) distribution including NY and OK, and country of Canada. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K071297 | IMPAX SE SIGMACOM CLIENT (PACS WORKSTATION) Agfa Healthcare Corp., Jun 22, 2007 |