Gentuity HF-OCT Imaging System Model G10-01; Software version 23.2.13;
FDA device recall Z-1823-2026 · posted 2026-04-16 · Open, Classified
Recall details
- Recalling firm
- Gentuity, LLC
- 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.
- Action taken
- On March 23, 2026, URGENT: MEDICAL DEVICE RECALL letters were sent to customers. Actions to be taken: The customers will be required to follow the updated instructions to correct for repeated frames per the revised Operator Manual to address longitudinal measurement accuracy until the updated version of the software that addresses this issue is installed on the console within 6 months.
- Root cause
- Device Design
- Status
- Open, Classified
- Product code
- DQO
- Quantity affected
- 184 units (28 US, 156 OUS)
- 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, G
- Date initiated
- 2026-03-23
- Date posted
- 2026-04-16
- Location
- Sudbury, MA
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| Gentuity® HF-OCT Imaging System with Vis-Rx Prime® Micro-Imaging Catheter (K242966) | Gentuity, LLC | 2025-01-31 |