Gentuity HF-OCT imaging systems may repeat frames during catheter pullback
Gentuity is issuing a correction for HF-OCT Imaging Systems because frames may repeat during pullback with Vis-Rx catheters, affecting longitudinal length measurements.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
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: FDA Class II correction addressing an imaging artifact that can distort length measurements used during intervention, a risk of harm with no injuries reported.
Plain-English summary
Gentuity is correcting the HF-OCT Imaging System, model G10-01, software version 23.2.13. The action covers 184 units, 28 in the United States and 156 elsewhere.
There is potential for repeated frames during HF-OCT pullback when using the Gentuity HF-OCT Console (software versions 21.11 to 23.3.13) with the Vis-Rx and Vis-Rx Prime catheters. The correction is intended to ensure that users are fully informed of how to recognise, avoid and mitigate this condition so that longitudinal (length) measurements during OCT imaging remain accurate. The FDA classified the action as Class II.
Distribution was nationwide in the United States, including California, Florida, Georgia, Illinois, Massachusetts, Minnesota, New Jersey, New York, Ohio, Pennsylvania and Texas, as well as internationally. The systems are used in catheterisation laboratories rather than sold to consumers.
Facilities should identify affected systems using the model number, UDI-DI and serial numbers in the recall notice and follow the instructions issued by Gentuity.
The recalled product
- Product
- Gentuity HF-OCT Imaging System Model G10-01; Software version 23.2.13;
- Manufacturer
- Gentuity, LLC
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
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