Recall Z-0033-2007 ยท LLZ System, Image Processing, Radiological
AGFA Corp.
IMPAX 5.2 Systems with CAD Capability (Computer Assisted Diagnosis)
| Date | Oct 12, 2006 (initiated Aug 8, 2006) |
| Status | Terminated |
| Reason | Failed CAD displayed as 'No Findings' |
| Root cause | Other |
| Action | Consignees were notified by letter on/about 08/08/2006. |
| Quantity | 20 Impax 5.2 Mammo licenses were issued domestically. |
| Distribution | Nationwide. |
| 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 |