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Medium risk Medical DevicesClass II

Gentuity HF-OCT Imaging System Recall

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

Updated March 23, 2026

The Gentuity HF-OCT Imaging System Model G10-01 with certain software versions can produce repeated frames during imaging pullbacks, which may lead to inaccurate length measurements in optical coherence tomography scans. Gentuity is working with users to ensure they understand how to recognize and avoid this issue.

Is the Gentuity, LLC recalled? Yes. This product was recalled by FDA on March 23, 2026. Details below.

What is recalled

Gentuity HF-OCT Imaging System Model G10-01 with software version 23.2.13, when used with Vis-Rx and Vis-Rx Prime catheters and Gentuity HF-OCT Console software versions 21.11 to 23.3.13.

Am I affected

You're affected if you operate a Gentuity HF-OCT Imaging System Model G10-01 with software version 23.2.13, and use Vis-Rx or Vis-Rx Prime catheters with HF-OCT Console software version 21.11 through 23.3.13.

What to do right now

Contact Gentuity, LLC directly for updated software and guidance on how to recognize and mitigate repeated frames during pullback procedures to ensure accurate longitudinal measurements.

The hazard

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.

Brands affected

Gentuity, LLC
Source
FDA
Category
Medical Devices
Recall ID
fda-Z-1823-2026
Classification
Class II
Recalled
March 23, 2026
Read the official notice

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