| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2013-RN-00317-1 |
| Product Name/Description |
IMPAX 5.2 DB Server, version 5.2 (Picture archiving and communication system, PACS)
ARTG Number: 127983 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class I |
| Recall Action Commencement Date |
18/04/2013 |
| Responsible Entity |
|
| Reason/Issue |
System downtime and/or slow performance may result if software in use is not at supported levels. To be specific, it has been identified that Oracle version 10.1.0.4.0 or older in use with IMPAX 5.2 DB Server can cause Oracle blocking sessions due to defect 360595 with fix available in Oracle 10.2.0.2 and subsequent versions. |
| Recall Action |
Recall for Product Correction |
| Recall Action Instructions |
Agfa HealthCare is advising that the ‘End of Service Life’ for IMPAX 5.2 was December 31, 2010. In order for Agfa HealthCare to continue to provide support, it is critical that sites upgrade to the latest version of IMPAX. In the interim, Agfa HealthCare strongly recommends installing the latest Oracle critical patch upgrades. Please see Oracle’s website for more details: http://www.oracle.com/technetwork/database/windows/downloads/index-101290.html . |
| Contact Information |
1300 364 612 - Agfa Healthcare Service Help Desk |