CLASS II Device recall · Reported 1 Aug 2012 · FDA Enforcement Report

Impax CV Reporting The Results Management recalled by AGFA

Agfa is recalling Impax CV Reporting The Results Management (RM)/Impax CV reporting component facilitates, distributed nationwide in the US. The recall was initiated on 10 Jul 2012 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesSoftware Version: RM 2.03 to 2.08, NIV 1.0

Quantity recalled6

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-2069-2012
FDA event ID: 62534
Recalling firm: Agfa, Greenville, SC
Classification: Class II
Status: Terminated
Recall initiated: 10 Jul 2012
FDA classified: 24 Jul 2012
Reported: 1 Aug 2012
Type: Voluntary: Firm initiated
Customers notified by: Telephone
Reason category: Other Reasons
Device type: Heart & Vascular Devices

Timeline

10 Jul 2012	Recall initiated by company
24 Jul 2012	Classified by FDA	+14 days
1 Aug 2012	Published in enforcement report	+8 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

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.

Product as listed by the FDA

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.

Where it was distributed

Nationwide Distribution including IN, SC, OH, TX

Nationwide Ohio South Carolina Texas

Questions about this recall

Why was it recalled?

Which lots are affected?

Software Version: RM 2.03 to 2.08, NIV 1.0

Where was it sold?

Nationwide Distribution including IN, SC, OH, TX

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

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