Gentuity, LLC is recalling 184 HF-OCT Imaging Systems (Model G10-01) because a software defect can cause the system to display repeated image frames. This error leads to inaccurate longitudinal length measurements during heart imaging procedures when using Vis-Rx and Vis-Rx Prime catheters. While no injuries have been reported, inaccurate measurements in medical imaging can lead to incorrect diagnosis or treatment decisions.
The software error creates repeated frames during a 'pullback' scan, which causes the system to calculate incorrect lengths of the imaged area. This can result in physicians receiving inaccurate data about the dimensions of a patient's anatomy during critical cardiac procedures.
Affected software versions include 21.11 through 23.3.13.
If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.
This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.
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Sources: FDA iRES · Raw API Response
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