Brand
Gentuity
1 federal recall on file. We monitor every CPSC, FDA, USDA, and NHTSA notice for Gentuity and translate it into plain English — free weekly digest, optional same-day alerts.
- 2026-04-22FDA-DeviceClass IICheck Gentuity HF-OCT system software version
The Gentuity HF-OCT Imaging System may display repeated image frames during a pullback procedure when used with certain catheters, which could affect the accuracy of length measurements. This issue affects specific software versions (21.11 to 23.3.13) paired with Vis-Rx and Vis-Rx Prime catheters. No injuries have been reported.
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