# FDA recall Z-1823-2026

> **Gentuity, LLC** · Class II · device recall initiated 2026-03-23.

## Product

Gentuity HF-OCT Imaging System Model G10-01;  Software version 23.2.13;

## Reason for recall

The potential for repeated frames during HF-OCT pullback when using the Gentuity HF-OCT Console (software version 21.11 to 23.3.13) with the Vis-Rx and Vis-Rx Prime catheters. This correction is intended to ensure that users are fully informed of how to recognize, avoid, and mitigate this condition to maintain accurate longitudinal (length) measurements during OCT imaging.

## Distribution

Domestic - US Nationwide distribution in the states of CA, FL, GA, IL, MA, MN, NJ, NY, OH, PA, TX;  International: United Arab Emirates, Belgium, Switzerland, Cyprus, Denmark, Spain, Finland, France, Greece, Italy, Japan, Kuwait, Latvia, Poland, Saudi Arabia, Slovakia;

## Key facts

- **Recall number:** Z-1823-2026
- **Recalling firm:** Gentuity, LLC
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2026-03-23
- **Report date:** 2026-04-22

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Sudbury, MA, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1823-2026

## Citation

> AI Analytics. FDA recall Z-1823-2026. Retrieved 2026-07-26 from https://api.ai-analytics.org/recall/Z-1823-2026. Source: US FDA. Licensed CC0.

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