[pending] Gentuity HF-OCT Imaging System Model G10-01; Software version 23.2.13;
Pending LLM rewrite. Source: FDA_DEVICE Z-1823-2026.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: Pending LLM scoring against the rubric.
Plain-English summary
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.
The recalled product
- Product
- Gentuity HF-OCT Imaging System Model G10-01; Software version 23.2.13;
- Manufacturer
- Gentuity, LLC
- Category
- Medical Device — Devices
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (20)
- 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
Distribution
Distributed nationwide across the United States.
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