# FDA recall Z-2652-2017

> **AGFA Healthcare Corp.** · Class II · device recall initiated 2016-12-22.

## Product

IMPAX Cardiovascular  The IMPAX CV Reporting module consists of a database and graphical user interface (GUI) that allows users to document procedure and clinical findings as structured data, with representation in printed or electronic formats

## Reason for recall

A customer experienced when using IMPAX CV Reporting software, specifically, when building a NIV report, the NIV Cardio report was showing incorrect findings for Aneurysm.

## Distribution

Nationwide Distribution to NJ, NC, OH, PA, SC, TN, TX, and WI

## Key facts

- **Recall number:** Z-2652-2017
- **Recalling firm:** AGFA Healthcare Corp.
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2016-12-22
- **Report date:** 2017-07-05
- **Termination date:** 2021-08-27

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Greenville, SC, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2652-2017

## Citation

> AI Analytics. FDA recall Z-2652-2017. Retrieved 2026-06-02 from https://api.ai-analytics.org/recall/Z-2652-2017. Source: US FDA. Licensed CC0.

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