Recall Z-1823-2026 · DQO Catheter, Intravascular, Diagnostic
Gentuity, LLC
Gentuity HF-OCT Imaging System Model G10-01; Software version 23.2.13;
| Date | Apr 16, 2026 (initiated Mar 23, 2026) |
| Status | Open, Classified |
| 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. |
| Root cause | Device Design |
| Action | 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. |
| Quantity | 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, Greece, Italy, Japan, Kuwait, Latvia, Poland, Saudi Arabia, Slovakia; |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K242966 | Gentuity® HF-OCT Imaging System with Vis-Rx Prime® Micro-Imaging Catheter Gentuity, LLC, Jan 31, 2025 |