Reported Aug 1, 2012 · Terminated
IMPAX CV Reporting The Results Management (RM)/IMPAX CV reporting component facilitates the quick, effective creating…
AGFA Corp.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: AGFA Corp. · 10 S Academy St · Greenville, SC · 29601-2632
Is this the product you have?
- IMPAX CV Reporting The Results Management (RM)/IMPAX CV reporting component facilitates the quick, effective creating
- of digital structured reports foradult 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
- Lot codes and dates
- Software Version
RM 2.03 to 2.08NIV 1.0
- Software Version
- Amount recalled
- 6
Where it was sold
Why it was recalled
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.
This product could cause temporary or reversible health problems — stop using it.
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