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 Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
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
Brand
AGFA Corp.
Lot Codes / Batch Numbers
Software Versions: 2.04.17, 2.04.19 and 2.04.20.
Products Sold
Software Versions: 2.04.17, 2.04.19 and 2.04.20.
AGFA Corp. is recalling Agfa IMPAX CardioVascular Suite Results Management Nuclear Reporting Module, Outbound Report, Model/ due to Reporting Differences: The Outbound Report software produces an Outbound Report (text version) which does not contain all the clinical content elemen. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
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.
Recommended Action
Per FDA guidance
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.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026