IMPAX CV Reporting The Results Management (RM)/IMPAX CV reporting component facilitates the quick, effective creating of digital structured reports for : adult catheterization and echocardiography, pediatric echocardiography, congenital heat disease, nuclear cardiology and non-invasive vascular disease management. This webb-based application allows cardiology departments to view, edit and sign the structured reports.
This recall has been terminated (originally issued July 24, 2012).
- Company
- Agfa Corp.
- Recall Initiated
- July 10, 2012
- Posted
- July 24, 2012
- Terminated
- October 29, 2013
- Recall Number
- Z-2069-2012
- Quantity
- 6
- Firm Location
- Greenville, SC
- Official Source
- View on FDA website ↗
Reason for Recall
When users selected "Left stenosis" in the "Graft Duplex Conclusion" section in IMPAX CV Reporting Non-Invasive(NIV) module, "Right stenosis" appeared in the sentence display within the printed representation of the report.
Distribution
Nationwide Distribution including IN, SC, OH, TX
Lot / Code Info
Software Version: RM 2.03 to 2.08, NIV 1.0
Root Cause
Error in labeling
Action Taken
AGFA Healthcare sent an Urgent Field Safety Notice dated July 10, 2012, to all affected consignees indicating that a representative from the IMPAX CV product management or professional services team would be contacting them to perform a review of their system. For questions customers were asked to call 401-604-2180. For questions regarding this recall call 864-421-1754.