FDAFDA · Food and drugs·Recall number Z-2069-2012
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.
Published August 1, 2012 · Recall initiated: July 10, 2012
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
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.
What to do
Voluntary: Firm initiated · Telephone
Recall details
- Manufacturer
- AGFA Corp.
- Distributor
- Nationwide Distribution including IN, SC, OH, TX
- Lot
- Software Version: RM 2.03 to 2.08, NIV 1.0
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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