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
This recall has been terminated (originally issued March 31, 2008).
- Company
- Agfa Corp.
- Recall Initiated
- February 22, 2008
- Posted
- March 31, 2008
- Terminated
- July 27, 2010
- Recall Number
- Z-1349-2008
- Quantity
- 5 units
- Firm Location
- Greenville, SC
- Official Source
- View on FDA website ↗
Reason for Recall
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.
Distribution
Nationwide to five hospitals in DC, NY, OH, TN, and VA.
Lot / Code Info
Software Versions: 2.04.17, 2.04.19 and 2.04.20.
Root Cause
Software design
Action Taken
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.