Gentuity HF-OCT imaging systems may repeat frames during catheter pullback

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

Category

Medical Device — Intravascular imaging system

Hazard

• imaging-artifact
• measurement-accuracy
• software-issue
• class-ii
• oct-imaging

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Distribution

Distributed nationwide across the United States.

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