FDA Device

IMPAX 5.2 DB Server (running Oracle 10.1.0.4.0), medical imaging Picture Archiving and Communication System (PACS).

Hazard

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.

What You Should Do

Remedy

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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Products

IMPAX 5.2 DB Server (running Oracle 10.1.0.4.0), medical imaging Picture Archiving and Communication System (PACS).
Brand
AGFA Corp.
UPC
N/A

Units Affected

4

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