Gentuity HF-OCT Imaging System Model G10-01; Software version 23.2.13;
FDA Recall Z-1823-2026 · Posted 2026-04-16
Advertisement
Recalling FirmGentuity, LLC
Recall StatusOpen, Classified
Product CodeDQO
Date Initiated2026-03-23
Product Quantity184 units (28 US, 156 OUS)
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.
Firm 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.
Root Cause
Device Design
Distribution Pattern
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;
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
Advertisement