Gentuity, LLC

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.

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

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, 26B0311, 26B2300, 26B1900, 26B1901, 26B1902;