Recall Z-1823-2026— Gentuity, LLC
Class II · Ongoing
Class II FDA medical device recall by Gentuity, LLC, initiated 2026-03-23. It names one FDA 510(k) clearance: K242966. Product: Gentuity HF-OCT Imaging System Model G10-01; Software version 23.2.13;. Reason: 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..
- Recalling firm
- Gentuity, LLC
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2026-03-23
- Firm location
- Sudbury, MA, United States
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
Product description
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.