FDA-Device2026-04-22Class IIPROCESSING DEFECT

Gentuity HF-OCT Imaging System recalled for potential repeated frames affecting measurement accuracy

OTHERNationwide distribution

Check 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.

Check if your Gentuity HF-OCT Console software version is between 21.11 and 23.3.13
If affected, contact Gentuity for guidance on recognizing and avoiding repeated frames during imaging
Verify measurement accuracy by comparing results with the steps provided by the manufacturer

Hazard

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.

Sold states

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;

Affected count

184 units (28 US, 156 OUS)

Manufactured in

142 North Rd Ste G, N/A, Sudbury, MA, United States

Products

Gentuity HF-OCT Imaging System Model G10-01; Software version 23.2.13;

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1823-2026

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