Recall Z-2069-2012 ยท LLZ System, Image Processing, Radiological
AGFA Corp.
IMPAX CV Reporting The Results Management (RM)/IMPAX CV reporting component facilitates the quick, effective creating of digital structured reports for : adult catheterization and echocardiography, pediatric echocardiography, congenital heat disease, nuclear cardiology and non-invasive vascular disease management. This webb-based application allows cardiology departments to view, edit and sign th
| Date | Jul 24, 2012 (initiated Jul 10, 2012) |
| Status | Terminated |
| Reason | When users selected "Left stenosis" in the "Graft Duplex Conclusion" section in IMPAX CV Reporting Non-Invasive(NIV) module, "Right stenosis" appeared in the sentence display within the printed representation of the report. |
| Root cause | Error in labeling |
| Action | AGFA Healthcare sent an Urgent Field Safety Notice dated July 10, 2012, to all affected consignees indicating that a representative from the IMPAX CV product management or professional services team would be contacting them to perform a review of their system. For questions customers were asked to call 401-604-2180. For questions regarding this recall call 864-421-1754. |
| Quantity | 6 |
| Distribution | Nationwide Distribution including IN, SC, OH, TX |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K050228 | AGFA HEARTLAB CARDIOVASCULAR Heartlab, Inc., Feb 18, 2005 |