Recall Z-0035-2014— AGFA Corp.

Name: FDA recall Z-0035-2014
Creator: U.S. Food and Drug Administration
Published: 2013-09-19

Class II · Terminated

Class II FDA medical device recall by AGFA Corp., initiated 2013-09-19, terminated 2013-10-24. It names one FDA 510(k) clearance: K071297. Product: IMPAX 5.2 DB Server (running Oracle 10.1.0.4.0), medical imaging Picture Archiving and Communication System (PACS).. 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..

Recalling firm: AGFA Corp.
Classification: Class II
Status: Terminated
Initiated: 2013-09-19
Terminated: 2013-10-24
Firm location: Greenville, SC, United States

510(k) clearances named in this recall

1 on FDA's record

K071297 — IMPAX SE SIGMACOM CLIENT (PACS WORKSTATION)Agfa Healthcare Corp.·cleared 2007-06-22

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

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

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.