Recall Z-2246-2011 ยท LLZ System, Image Processing, Radiological
AGFA Corp.
IMPAX 6.5 Client Software. IMPAX 6.5 combines the traditional activities of RIS informatics management with PACS image management to provide a powerful platform for imaging-based planning, interpretation, and results distribution. The IMPAX 6.5 Client focuses on the integration of PACS, RIS and Speech applications into a single delivery of information. A single IMPAX 6.5 Client application can be
| Date | May 24, 2011 (initiated Apr 5, 2011) |
| Status | Terminated |
| Reason | Software issue that occurs after dictation of a study. |
| Root cause | Other |
| Action | Agfa Corp. sent an "URGENT SAFETY NOTICE" customer letter via Agfa email to customers on 4/14/2011, along with a "URGENT SAFETY NOTICE FEEDBACK FORM," The letter identified the product , the problem, and the action to be taken by the customer. It was discovered a software issue in the IMPAX 6.5. The upgrade has already been released to address the software problem. Customers were instructed to fax back the feedback form as soon as possible to (864) 421-1664. If you have any questions, please contact your local Agfa Healthcare organization. |
| Quantity | 95 units |
| Distribution | Nationwide Distribution -- including states of WI, and SC. |
| 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 |