Gentuity, LLC recalls Gentuity HF-OCT Imaging System

Recalling company

Gentuity, LLC

Product

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

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.

Classification

Class II – may cause temporary or medically reversible health consequences

Recall date

Mar 23, 2026

Reported

Apr 22, 2026

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;

Status

Ongoing

Quantity

184 units (28 US, 156 OUS)

Lot / codes

Model Number: G10-01; UDI-DI: 00859910007032; Lot/Serial Number: 23C0113, 22J0101, 20A0202, 23F0101, 22F0113, 22L0100, 26B0203, 26B0200, 26B0204, 26B0202, 26B0201, 25L0302, 22E0204, 22J0102, 24H0101, 24H0102, 23K0201, 20A0203, 22K0306, 20A0201, 25J0200, 23C0110, 22K0305, 25E0100, 22F0110, 22K0304, 22K0302, 24B0107; OUS Lot numbers: 21G1900, 21G1901, 21G1902, 21G1903, 21G1904, 21H1101, 21H1102, 21H1103, 21H1104, 21H1105, 22C2300, 22C2301, 22C3000, 22D2600, 22D2700, 22D2701, 22D2702, 22D2705, 22E0500, 22E0501, 22F2700, 22F2701, 22F2702, 22F2703, 22F2704, 22G2600, 22G2601, 22G2700, 22H2900, 22H2901, 24B2100, 24B2101, 24B2102, 24B2103, 24B2104, 24C1301, 24C1302, 24C1303, 24C1304, 24C1305, 24D1504, 24D1505, 24D1506, 24D1507, 24D1508, 24E0800, 24E0801, 24E0802, 24E0803, 24E0804, 24F2408, 24F2409, 24F2410, 24F2411, 24F2412, 24G2205, 24G2206, 24G2207, 24G2208, 24G2209, 24H1400, 24H1401, 24H1402, 24H1403, 24H1404, 24M1000, 22L3000, 22L3001, 23A1904, PDA23-001, 23C2202, 23C2203, 23E0900, 23E0901, 23E0902, 23F2704, 23F2705, 23G2601, 23G2602, 23G2603, 23G2604, 23G0700, 23G0701, 23H3000, 23H3001, 23H3002, 23H3003, 23M1102, 23M1103, 23M1104, 23M1301, 24B2105, 24B2106, 24C2200, 24C2201, 24H1900, 24H1901, 24H1902, 24J0500, 24J0501, 24J0502, 24M1101, 24M1102, 24M1103, 24M1104, 24M1105, 25C0320, 25C0321, 25C0322, 25C0323, 25C0324, 25F2500, 25F2501, 25F2502, 25G3103, 25G3104, 25G3105, 25J0800, 25J0801, 25J0802, 25J2300, 25K0909, 25K0910, 25L0306, 25L0307, 25M0203, 25M0201, 25M0202, 26B0310, 26B

Company location

Sudbury, MA

Recall type

Voluntary: Firm initiated

Recall number

Z-1823-2026

Agency

U.S. Food and Drug Administration (FDA)

View official FDA notice ↗ Search recall number Z-1823-2026 in the FDA Enforcement Report. Also see FDA recall press releases.