FDA recall, , Moderate risk
Gentuity HF-OCT Imaging System
The Gentuity HF-OCT Imaging System may show repeated frames during pullback, affecting length measurements.
Summary by Recall Canary from the FDA notice
What happened
Gentuity, LLC of Sudbury, Massachusetts, is correcting its Gentuity HF-OCT Imaging System Model G10-01, including software version 23.2.13, due to 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 condition could affect accurate longitudinal (length) measurements during OCT imaging. The correction is intended to ensure users are fully informed of how to recognize, avoid, and mitigate this condition.
The company began the recall on March 23, 2026, and it was added to the FDA's Enforcement Report on April 16, 2026. The product was distributed in the United States in California, Florida, Georgia, Illinois, Massachusetts, Minnesota, New Jersey, New York, Ohio, Pennsylvania and Texas, and internationally in United Arab Emirates, Belgium, Switzerland, Cyprus, Denmark, Spain, Finland, France, Greece, Italy, Japan, Kuwait, Latvia, Poland, Saudi Arabia and Slovakia.
What to do
We don't have product-specific instructions for this recall. FDA's general advice for medical device recalls:
- A device recall doesn't always mean you must stop using it: it may need to be checked, adjusted or fixed.
- Talk to your health care provider before you stop using it.
Is yours affected?
Match the model number, UDI-DI and lot code listed under your product.
A UDI-DI is the device identifier printed with the barcode on the device label.
Gentuity HF-OCT Imaging System
- Model number
- G10-01
- UDI-DI
- 00859910007032
- Lot code
- 21G1900
- 21G1901
- 21G1902
- 21G1903
- 21G1904
- 21H1101
- 21H1102
- 21H1103
- 21H1104
- 21H1105
- 22C2300
- 22C2301
- 22C3000
- 22D2600
- 22D2700
- 22D2701
- 22D2702
- 22D2705
- 22E0500
- 22E0501
- 22F2700
- 22F2701
- 22F2702
- 22F2703
- 22F2704
- 22G2600
- 22G2601
- 22G2700
- 22H2900
- 22H2901
- 24B2100
- 24B2101
- 24B2102
- 24B2103
- 24B2104
- 24C1301
- 24C1302
- 24C1303
- 24C1304
- 24C1305
- 24D1504
- 24D1505
- 24D1506
- 24D1507
- 24D1508
- 24E0800
- 24E0801
- 24E0802
- 24E0803
- 24E0804
- 24F2408
- 24F2409
- 24F2410
- 24F2411
- 24F2412
- 24G2205
- 24G2206
- 24G2207
- 24G2208
- 24G2209
- 24H1400
- 24H1401
- 24H1402
- 24H1403
- 24H1404
- 24M1000
- 22L3000
- 22L3001
- 23A1904
- PDA23-001
- 23C2202
- 23C2203
- 23E0900
- 23E0901
- 23E0902
- 23F2704
- 23F2705
- 23G2601
- 23G2602
- 23G2603
- 23G2604
- 23G0700
- 23G0701
- 23H3000
- 23H3001
- 23H3002
- 23H3003
- 23M1102
- 23M1103
- 23M1104
- 23M1301
- 24B2105
- 24B2106
- 24C2200
- 24C2201
- 24H1900
- 24H1901
- 24H1902
- 24J0500
- 24J0501
- 24J0502
- 24M1101
- 24M1102
- 24M1103
- 24M1104
- 24M1105
- 25C0320
- 25C0321
- 25C0322
- 25C0323
- 25C0324
- 25F2500
- 25F2501
- 25F2502
- 25G3103
- 25G3104
- 25G3105
- 25J0800
- 25J0801
- 25J0802
- 25J2300
- 25K0909
- 25K0910
- 25L0306
- 25L0307
- 25M0203
- 25M0201
- 25M0202
- 26B0310
- 26B0311
- 26B2300
- 26B1900
- 26B1901
- 26B1902
Recall details
- Company began the recall
- Sold in
Domestic - US Nationwide distribution in the states of California, Florida, Georgia, Illinois, Massachusetts, Minnesota, New Jersey, New York, Ohio, Pennsylvania, Texas; International: United Arab Emirates, Belgium, Switzerland, Cyprus, Denmark, Spain, Finland, France, Greece, Italy, Japan, Kuwait, Latvia, Poland, Saudi Arabia, Slovakia;
- Company
- Gentuity, LLCSudbury, Massachusetts
- Hazard
- Software defect
- Risk
Moderate risk
Using it may cause short-term health problems, or ones that treatment can reverse. Serious harm is unlikely.
FDA Class II recall · How risk is rated
- Event ID
- 98619
- Recall number
- Z-1823-2026
- Quantity recalled
- 184 units (28 US, 156 OUS)
Timeline
FDA's Enforcement Report is its public list of recalls; FDA adds a recall when it posts it and publishes the list weekly.
Company began the recall
Added to FDA's Enforcement Report · Classified by FDA
In FDA's weekly enforcement report
Listed on Recall Canary
Summary updated
