Recall Z-1243-2008 ยท LLZ System, Image Processing, Radiological
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.
| Date | Sep 11, 2008 (initiated May 14, 2007) |
| Status | Terminated |
| Reason | Java version 1.6x (JAVA 6) is not compatible with AGFA IMPAX Administration/Service Tools. Due to a Software Mismatch data can be lost. |
| Root cause | Software change control |
| Action | 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 s |
| Quantity | 946 units (total for both types of software) |
| Distribution | U.S. Nationwide and Canada. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K022292 | IMPAX DIAGNOSTIC DISPLAY STATION,IMPAX CLINICAL REVIEW STATION,IMPAX FOR CARDIOLOGY CLINICAL REVIEW SATATION,IMPAX ORTHO Agfa Corp., Sep 12, 2002 |
| K040555 | IMPAX CLIENT EMBRACE Agfa Corp., May 26, 2004 |
| K050228 | AGFA HEARTLAB CARDIOVASCULAR Heartlab, Inc., Feb 18, 2005 |
| K050751 | IMPAX ORTHOPAEDIC WORKSTATION, MODEL IMPAX ES 5.X Agfa Corp., Apr 21, 2005 |
| K053458 | WEB1000 Agfa Corp., Dec 22, 2005 |