Gentuity HF-OCT Imaging System SW 23.3.13Recalls & reported problems
Gentuity LLC · Gentuity OCT imaging console, including optical engine, PC, PIM with umbilical, 2 monitors (one with touch screen) and keyboard/mouse. · Class 2
Data updated Oct 18, 2026 from official FDA records · Editorial policy
1 open recall names this device. See the recall details and contact the manufacturer or your healthcare provider.
- Adverse event reports
- 0
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 1
Summary
No MAUDE adverse event reports in our data reference this device identifier directly.
1 FDA recall record name this device's identifier, 1 still open.
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.
Recalls naming this device
- Mar 23, 2026Class IIOpen, Classified
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.
Z-1823-2026 · Root cause: Device Design · Recall details · FDA record ↗
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- NvisionVLE Low Profile Imaging Probe, 0mm Working Distance 95501-LPNinepoint Medical, Inc. · System, Imaging, Optical Coherence Tomography (Oct)2 reports
- NvisionVLE Marking Probe 20mm 95301-M-20Ninepoint Medical, Inc. · System, Imaging, Optical Coherence Tomography (Oct)2 reports
- ILUMIEN™ 900-700-00Lightlab Imaging, Inc. · SYSTEM, IMAGING, OPTICAL COHERENCE TOMOGRAPHY (OCT)1 report
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026 · each recall links to the FDA recall notice
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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