Recall Z-1887-2009 ยท LLZ System, Image Processing, Radiological
AGFA Corp.
Agfa Impax R6.3 DB Server. Impax Systems are Picture Archiving and Communication systems (PACs). PAC systems are used in the acceptance, transfer, display, storage and digital processing of medical images. Primary users are radiologists, mammographers, orthopaedists and other trained medical staff.
| Date | Sep 8, 2009 (initiated Jul 16, 2009) |
| Status | Terminated |
| Reason | Measurements are inaccurate on multiple workstations. |
| Root cause | Software design |
| Action | Agfa Healthcare issued an "URGENT FIELD SAFETY NOTICE" dated July 16, 2009. The notice informed of the problem and provided details to identify potentially compromised data that could result in measurement inaccuracies. A feedback form was provided to be completed and returned to the firm. For further information, contact Agfa Healthcare at 1-773-592-4769. |
| Quantity | One unit |
| Distribution | Nationwide Distribution -- IL |
| 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 |