Official recall notice
FDA Recall: Gentuity HF-OCT Imaging System Model G10-01; Software version 23.2.13;
- Recall date
- 2026-04-22
- Brand
- Gentuity, LLC
- Category
- Medical Device
- FDA class
- Class II
Why it was recalled
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.
Recommended action
What to do
184 units (28 US, 156 OUS)
Product description
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.