Gentuity HF-OCT Imaging System Model G10-01; Software version 23.2.13;
| Source | FDA Device Enforcement |
|---|---|
| Category | Medical Device |
| Severity | Medium |
| Status | ongoing |
| Recall date | March 23, 2026 |
| Reported | April 22, 2026 |
| Recalling firm | Gentuity, LLC |
| Country / region | United States MA |
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.
Affected products
- Gentuity HF-OCT Imaging System Model G10-01; Software version 23.2.13;
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