FDAMarch 23, 2026device
Gentuity HF-OCT Imaging System Model G10-01; Software version 23.2.13;
Official recall recorded by the U.S. Food & Drug Administration.
The hazard
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.
What to do
FDA enforcement status: Ongoing
Brands named
gentuity
UPCs
00859910007032
Recall history
No related federal recalls on record for this brand yet.
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