Z-1823-2026 Class II Ongoing
FDA device recall Z-1823-2026 was initiated by Gentuity, LLC on March 23, 2026 and is designated Class II. Reason for recall: 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 inten… The recall status is ongoing. Affected quantity: 184 units (28 US, 156 OUS).
Recall Details
- Product Type
- Devices
- Report Date
- April 22, 2026
- Initiation Date
- March 23, 2026
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 184 units (28 US, 156 OUS)
Product Description
Gentuity HF-OCT Imaging System Model G10-01; Software version 23.2.13;
Reason for Recall
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.
Distribution Pattern
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;
Code Information
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;