Class II — Potential Health Hazard

Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.

IMPAX CV 7.8 SU3 - OCR Service. The IMPAX CV Recalled by AGFA Corp. Due to Software design error in IMPAX CV 7.8 SU3

Date: March 15, 2013
Company: AGFA Corp.
Status: Terminated
Source: FDA (Device)

What You Should Do

Stop using this product immediately. Do not consume, use, or distribute it.

Return the product to the place of purchase for a full refund. If you have questions, contact AGFA Corp. directly.

Affected Products

IMPAX CV 7.8 SU3 - OCR Service. The IMPAX CV Reporting component facilitates the quick , effective creation of digital structured reports for adult catheterization and echocardiography, pediatric echocardiography, congenital heart disease, nuclear cardiology and non-invasive vascular disease management.

Quantity: 2

Why Was This Recalled?

Software design error in IMPAX CV 7.8 SU3

Where Was This Sold?

This product was distributed to 2 states: FL, KY

Affected (2 states)Not affected

About AGFA Corp.

AGFA Corp. has 11 total recalls tracked by RecallDetector.

Related Recalls

Data sourced from the FDA (Device). Last updated March 26, 2026. View original report