Gentuity recalls specific software versions of their HF-OCT Imaging System Model G10-01 due to potential repeated frames during catheter pullback, which may affect measurement accuracy. Affected units include certain serial numbers and software versions.
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.
Gentuity is recalling specific versions of their HF-OCT Imaging System Model G10-01 software (version 23.2.13) because it can cause repeated frames during catheter pullback, potentially leading to inaccurate length measurements in imaging. This issue does not pose a safety risk but affects the accuracy of the imaging results.
The software version 21.11 to 23.3.13 can cause repeated frames during the pullback process when using certain catheters. This may result in inaccurate longitudinal measurements during OCT imaging, but it does not cause physical harm or injury.
Medical professionals using the Gentuity HF-OCT Imaging System Model G10-01 with specific software versions and catheters (Vis-Rx and Vis-Rx Prime) are likely affected. Patients undergoing imaging procedures with these devices may be at risk of inaccurate measurements.
Check if your device has the model number G10-01 and software version 23.2.13. Affected units include specific serial numbers listed in the recall notice, such as 23C0113, 22J0101, and others.
Verify your software version by checking the device settings or documentation. If it is version 23.2.13 or within the affected range (21.11 to 23.3.13), it may be affected.
No, the recall does not pose a safety risk. The issue only affects measurement accuracy during imaging, not physical safety.
Check your software version and serial number. If affected, you may need to update to a newer software version to ensure accurate measurements.
Look for the model number G10-01 and software version 23.2.13 on your device. Affected serial numbers are listed in the recall notice.
We’ve drafted a message you can send Gentuity to request your refund or repair — edit it as you like.
Subject: Recall Z-1823-2026 — Gentuity Gentuity Hello, I own a Gentuity that is covered by recall Z-1823-2026 from Gentuity. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
