Recall Z-1349-2008 ยท LLZ System, Image Processing, Radiological
AGFA Corp.
Agfa IMPAX CardioVascular Suite Results Management Nuclear Reporting Module, Outbound Report, Model/Catalog No.: L7W1P, Software Versions: 2.04.17, 2.04.19 and 2.04.20, AGFA HealthCare, Westerly, RI
| Date | Mar 31, 2008 (initiated Feb 22, 2008) |
| Status | Terminated |
| Reason | Reporting Differences: The Outbound Report software produces an Outbound Report (text version) which does not contain all the clinical content elements present in the PDF version of the report, also generated on the Nuclear Cardiology Reporting Module. |
| Root cause | Software design |
| Action | All five (5) sites utilizing this product were notified about the issue directly via telephone. An "Urgent Safety Notice" was sent via FED-EX to all the sites using the product on February 22, 2008. The letter describes the potential issue and mitigation. The recalling firm will also visit each site and make configuration changes to resolve this issue. |
| Quantity | 5 units |
| Distribution | Nationwide to five hospitals in DC, NY, OH, TN, and VA. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K050228 | AGFA HEARTLAB CARDIOVASCULAR Heartlab, Inc., Feb 18, 2005 |