Recall Z-0272-2012 ยท LLZ System, Image Processing, Radiological
AGFA Corp.
IMPAX CardioVascular (CV) Admin Tool The IMPAX Cardiovascular suite is a cardiovascular information system providing image archiving and image display and modality study-specific structured reporting.
| Date | Nov 23, 2011 (initiated Jun 6, 2011) |
| Status | Terminated |
| Reason | Potential for misattribution of data and for a report to become unavailable when the user requests for it to be moved to another study that already has a report associated with it. |
| Root cause | Software design |
| Action | An 'URGENT FIELD SAFETY NOTICE" was sent via FED-EX by June 6, 2011 to all the sites using the affected product. The letter described the issue and mitigation. The letter recommends that users not move reports to studies where a report already exists. If a report is being moved because the existing report is irrelevant to the study, then the existing report should be deleted prior to moving the new report to that study. If the report is being moved because the user wants to combine the content of the reports, then the "merge" function should be utilized. The letter also states that a soft |
| Quantity | 323 units |
| Distribution | Worldwide Distribution -- USA, Virgin Islands and Canada |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K050228 | AGFA HEARTLAB CARDIOVASCULAR Heartlab, Inc., Feb 18, 2005 |