Reported Apr 22, 2026 · Ongoing
Gentuity HF-OCT Imaging System Model G10-01; Software version 23.2.13;
Gentuity, LLC
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Gentuity, LLC · 142 North Rd Ste G · Sudbury, MA · 01776-1142
Is this the product you have?
Gentuity HF-OCT Imaging System Model G10-01Software version 23.2.13
- Lot codes and dates
- Model NumberG10-01
- UDI-DI00859910007032
- Lot/Serial Number
23C011322J010120A020223F010122F011322L010026B020326B020026B020426B020226B020125L030222E020422J010224H010124H010223K020120A020322K030620A020125J020023C011022K030525E010022F011022K030422K030224B0107
- OUS Lot numbers
134 of 134 codes
21G190021G190121G190221G190321G190421H110121H110221H110321H110421H110522C230022C230122C300022D260022D270022D270122D270222D270522E050022E050122F270022F270122F270222F270322F270422G260022G260122G270022H290022H290124B210024B210124B210224B210324B210424C130124C130224C130324C130424C130524D150424D150524D150624D150724D150824E080024E080124E080224E080324E080424F240824F240924F241024F241124F241224G220524G220624G220724G220824G2209
- Amount recalled
- 184 units (28 US, 156 OUS)
Where it was sold
Why it was recalled
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.
This product could cause temporary or reversible health problems — stop using it.
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