IMPAX 5.2 DB Server (running Oracle 10.1.0.4.0), medical imaging Picture Archiving and Communication System (PACS).
- Company
- Agfa Corp.
- Recall Initiated
- September 19, 2013
- Posted
- October 21, 2013
- Terminated
- October 24, 2013
- Recall Number
- Z-0035-2014
- Quantity
- 4
- Firm Location
- Greenville, SC
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.
Distribution
Worldwide distrbution: US(nationwide) distribution including NY and OK, and country of Canada.
Root Cause
Software in the Use Environment
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.
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