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Gentuity HF-OCT Imaging System Model G10-01 recallZ-1823-2026 · Gentuity, LLC · initiated Mar 23, 2026

Open, Classified

Is my device affected?

  1. Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
  2. If yours is listed, follow the instructions from Gentuity, LLC or your healthcare provider. The company's action is summarized under what the company is doing.
  3. Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

Why it was recalled

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.

FDA root cause category: Device Design

What the company is doing

On March 23, 2026, URGENT: MEDICAL DEVICE RECALL letters were sent to customers. Actions to be taken: The customers will be required to follow the updated instructions to correct for repeated frames per the revised Operator Manual to address longitudinal measurement accuracy until the updated version of the software that addresses this issue is installed on the console within 6 months.

Recall details

Recall number
Z-1823-2026
Status
Open, Classified
Initiated by the company
Mar 23, 2026
Posted by the FDA
Apr 16, 2026
Recalling firm
Gentuity, LLC
Quantity
184 units (28 US, 156 OUS)
Product code
DQO
FDA submissions
K242966
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;

Product description

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

Code information (models, lots, serial numbers)

Show the full code information (2k characters)

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;

Devices named in this recall

1 device in the FDA device registry whose identifier appears in the recall's code information.

Sources and updates

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