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Terminated

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

FDA Recall Z-0035-2014 · Posted 2013-10-21

Recalling FirmAGFA Corp.
Recall StatusTerminated
Product CodeLLZ
Date Initiated2013-09-19
Date Terminated2013-10-24
Product Quantity4

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.

Firm 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.

Root Cause

Software in the Use Environment

Distribution Pattern

Worldwide distrbution: US(nationwide) distribution including NY and OK, and country of Canada.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K071297IMPAX SE SIGMACOM CLIENT (PACS WORKSTATION)Agfa Healthcare Corp. · 2007-06-22

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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