Gentuity, LLC recalls Gentuity HF-OCT Imaging System Model G10-01; Software version 23.2.13;
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…
Read the official notice →- Date
- 2026-04-22
- Country
- United States
- Brand
- Gentuity, LLC
- Product
- Gentuity HF-OCT Imaging System Model G10-01; Software version 23.2.13;
- Classification
- Class II
- Units
- Domestic - US Nationwide distribution in the states of CA, FL, GA, IL, MA, MN,…
- Category
- Drugs & medical
- Source
- FDA · Device
Copied automatically from the US Food and Drug Administration. Details may be shortened or out of date; the official notice is the authoritative source. Disclaimer
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- Check the product name, strength and lot number against the official notice.
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General guidance from Recall Atlas. The official notice from the US Food and Drug Administration has the exact models, batch codes and remedy, and it takes priority.
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