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Gentuity HF-OCT Imaging System
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MEDICAL DEVICE RECALLMODERATE

Gentuity HF-OCT Imaging System

Gentuity is correcting HF-OCT Imaging System software (versions 21.11–23.3.13) to prevent inaccurate longitudinal measurements during imaging.

What to do

Review the updated instructions provided by Gentuity to recognize, avoid, and mitigate the potential for repeated frames during pullback procedures to ensure measurement accuracy.

Recalled
Listed
Updated
Recall No.
Z-1823-2026
Agency
FDA
Firm
Gentuity, LLC
Recall ID
98619
Status
ONGOING

Recall at a glance

Quantity recalled
184 units (28 US, 156 OUS)

Why it was recalled

Gentuity is issuing a correction for the HF-OCT Imaging System, Model G10-01, running software versions 21.11 through 23.3.13. The system may experience repeated frames during pullback when used with Vis-Rx and Vis-Rx Prime catheters, which can lead to inaccurate longitudinal measurements.

Is mine affected?

Check the model, lot, or serial number on the device or its packaging. Yours is affected if it matches one below.

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

UDI-DI
00859910007032

Where it was sold

Distributed nationwide.

Timeline

  1. Firm initiated recall
  2. Publicly announced
  3. Listed on Recall Canary
  4. Summary updated

Official source

View on U.S. Food and Drug Administration →

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Editorial summary by Recall Canary · summary updated 2026-06-11 · primary source: U.S. Food and Drug Administration · severity reflects the agency's published classification