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.
FDA Recall Z-0272-2012 · Posted 2011-11-23
Recalling FirmAGFA Corp.
Recall StatusTerminated
Product CodeLLZ
Date Initiated2011-06-06
Date Terminated2012-06-26
Product Quantity323 units
Reason for Recall
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.
Firm 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 software enhancement is currently available. Acknowledgment via FAX-Back was requested from the sites. Questions regarding the issue should be directed to customers' local Agfa HealthCare Service at 877-777-2432. The firm has identified 185 additional sites and an "URGENT FIELD SAFETY NOTICE" was sent on October 12, 2012.
Root Cause
Software design
Distribution Pattern
Worldwide Distribution -- USA, Virgin Islands and Canada
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.