AGFA Corp.: Medical Device Recall in 2012 - (Recall #: Z-2069-2012)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2012.

Data Source: FDA.

Product Description:

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.

Product Classification:

Class II

Date Initiated: July 10, 2012

Date Posted: August 1, 2012

Recall Number: Z-2069-2012

Event ID: 62534

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.

Status: Terminated

Product Quantity: 6

Code Information:

Software Version: RM 2.03 to 2.08, NIV 1.0

Distribution Pattern:

Nationwide Distribution including IN, SC, OH, TX

Voluntary or Mandated:

Voluntary: Firm initiated