AGFA Corp. IMPAX 4.1, IMPAX 4.5, IMPAX 5.0, IMPAX 5.1 IMPAX 5.2, IMPAX 6.0, IMPAX 6.2; Picture Archiving and Communications systems (PACs), used in the acceptance, transfer, display, storage and digital processing of medical images. Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
IMPAX 4.1, IMPAX 4.5, IMPAX 5.0, IMPAX 5.1 IMPAX 5.2, IMPAX 6.0, IMPAX 6.2; Picture Archiving and Communications systems (PACs), used in the acceptance, transfer, display, storage and digital processing of medical images.
Brand
AGFA Corp.
Lot Codes / Batch Numbers
IMPAX¿ 4.1, Catalog Number: LHZQN007, IMPAX ¿ 4.5, Catalog Number: LZTJM, IMPAX ¿ 5.0, Catalog Number: L3CJE, IMPAX ¿ 5.1 Catalog Number: L4AW6, IMPAX ¿ 5.2, Catalog Number: L4EM2, IMPAX ¿ 6.0, Catalog Number: L73V4, IMPAX ¿ 6.2, Catalog Number: EWMDT.
Products Sold
IMPAX¿ 4.1, Catalog Number: LHZQN007; IMPAX ¿ 4.5, Catalog Number: LZTJM; IMPAX ¿ 5.0, Catalog Number: L3CJE; IMPAX ¿ 5.1 Catalog Number: L4AW6; IMPAX ¿ 5.2, Catalog Number: L4EM2; IMPAX ¿ 6.0, Catalog Number: L73V4; IMPAX ¿ 6.2, Catalog Number: EWMDT.
AGFA Corp. is recalling IMPAX 4.1, IMPAX 4.5, IMPAX 5.0, IMPAX 5.1 IMPAX 5.2, IMPAX 6.0, IMPAX 6.2; Picture Archiving due to Java version 1.6x (JAVA 6) is not compatible with AGFA IMPAX Administration/Service Tools. Due to a Software Mismatch data can be lost.. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Java version 1.6x (JAVA 6) is not compatible with AGFA IMPAX Administration/Service Tools. Due to a Software Mismatch data can be lost.
Recommended Action
Per FDA guidance
Agfa Healthcare contacted all consignees on 5/14/2007 and by registered mail on 06/07/2007. The registered Urgent Field Safety Notice letters requested the accounts take the following steps immediately: 1. Turn off automatic JAVA updates to avoid this update being applied in the background. 2. Do not manually update JAVA on their station-even for other applications. 3. If JAVA 1.6 has already been applied, do not use Service/Admin Tools. They were instructed to contact their IT department or Agfa support for assistance in backing out of this version to apply the required version for the Agfa software. A Mandatory Service Bulletin will inform and assist affected account in removing JAVA 1.6 if it has been applied and turning off the automatic updates via the JAVA Plug-in Control Panel.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026