Gentuity HF-OCT Imaging System Model G10-01 — Class II medical device recall Z-1823-2026
Ongoing recall by Gentuity, LLC, reported 2026-04-22, distributed nationwide. The potential for repeated frames during HF-OCT pullback when using the Gentuity HF-OCT Console (software vers
| Recall number | Z-1823-2026 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Gentuity, LLC, Sudbury, MA, United States |
| Recall initiated | 2026-03-23 |
| Classified | 2026-04-16 |
| Reported by FDA | 2026-04-22 |
| Distributed | Nationwide (US) |
| Countries outside the US | AE, BE, CH, CY, DK, ES, FI, FR, GR, IT, JP, KW, LV, PL, SA, SK |
| Reason classes | software |
| UPC / GTIN / UDI-DI | 00859910007032 |
| 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, 22L3000, 22L3001, 23A1904, 23C2202, 23C2203, 23E0900, 23E0901, 23E0902, 23F2704, 23F2705 and 94 more |
| Serial numbers | 20A0201, 20A0202, 20A0203, 22E0204, 22F0110, 22F0113, 22J0101, 22J0102, 22K0302, 22K0304, 22K0305, 22K0306, 22L0100, 23C0110, 23C0113, 23F0101, 23K0201, 24B0107, 24H0101, 24H0102, 25E0100, 25J0200, 25L0302, 26B0200, 26B0201 and 3 more |
| Model numbers | G10-01 |
Product
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1823-2026. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.