Gentuity HF-OCT Imaging System Model G10-01; Software version 23.2.13;
USGentuity HF-OCT Imaging System Model G10-01; Software version 23.2.13;
Recalling Firm: Gentuity, LLC
Motivo del Retiro / Peligro
TranslatedThe 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.
Descripción del Producto e Identificación
TranslatedGentuity HF-OCT Imaging System Model G10-01; Software version 23.2.13;
Productos Afectados
TranslatedGentuity HF-OCT Imaging System Model G10-01; Software version 23.2.13;
Additional Source Details
| Field | Value |
|---|---|
| City | Sudbury |
| State | MA |
| Event id | 98619 |
| Address 1 | 142 North Rd Ste G |
| Address 2 | N/A |
| Code info | Model Number: G10-01; UDI-DI: 00859910007032; Lot/Serial Number: 23C0113, 22J0101, 20A0202, 23F0101, 22F0113, 22L0100, 26B0203, 26B0200, 26B0204, 26B0202, 26B0201, 25L0302, 22E0204, 22J0102, 24H0101, 24H0102, 23K0201, 20A0203, 22K0306, 20A0201, 25J0200, 23C0110, 22K0305, 25E0100, 22F0110, 22K0304, 22K0302, 24B0107; OUS Lot numbers: 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... [TRUNCATED] |
| Postal code | 01776-1142 |
| Report date | 20260422 |
| Product type | Devices |
| Product quantity | 184 units (28 US, 156 OUS) |
| Reason for recall | 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. |
| Voluntary mandated | Voluntary: Firm initiated |
| Recall initiation date | 20260323 |
| Initial firm notification | Letter |
| Center classification date | 20260416 |
Consumer Action Protocol: What You Should Do Immediately
Safety StepsInspect the NDC code, batch number, or control number on your medicine bottle or blister packaging to confirm whether your unit is included.
Do not abruptly stop critical prescribed medication without physician advice. Contact your dispensing pharmacist immediately for a safe alternative.
Under statutory consumer protection rules, consumers are entitled to a full refund, certified replacement, or free repair kit without needing the original sales receipt.
If you suffered an injury, illness, or property damage from this product, file an official incident report with regulatory authorities (FDA Devices).
Your Legal Rights as a Consumer
Recalls are legally binding corrective safety actions overseen by statutory government bodies. Recalling entities are legally prohibited from charging consumers for official safety remedies. If a retailer or dealership refuses your recall remedy, notify the issuing regulatory agency immediately.
Frequently Asked Questions About This Recall
FAQ GuideQ1:What should I do immediately if I own or bought Gentuity HF-OCT Imaging System Model G10-01; Software version 23.2.13;?
Check the lot number and NDC on your prescription label. For essential medications, consult your doctor or dispensing pharmacist immediately before abruptly stopping your dose.
Q2:Can I get a full refund or free repair for this recall?
Yes. Recalling manufacturers and retail merchants are required under consumer protection regulations to offer a statutory remedy—typically a full refund, certified repair kit, or replacement unit.
Q3:Do I need my original sales receipt to claim a remedy or refund?
In most recall cases, no receipt is required. Because safety recalls are matters of public health and statutory compliance, retailers and manufacturers routinely issue refunds, store credit, or replacement kits upon presentation of the affected product or lot code.
Q4:Where can I verify official information for this safety alert?
This safety alert is aggregated directly from official regulatory agency records (FDA Devices). You can click the 'Official Agency Alert' link on this page to view the primary government notice and contact the manufacturer directly.
Revise otros productos en su hogar
Herramientas GratuitasSafety recalls are issued daily across foods, medications, vehicles, and electronics. Use our instant tools to check your home for active safety warnings:
Resumen
- Empresa ResponsableGentuity, LLC
- StatusOngoing
- Nivel de RiesgoClass II
- DistributionDomestic - US Nationwide distribution in the states of CA, FL, GA, IL, MA, MN, NJ, NY, OH, PA, TX; International: United Arab Emirates, Belgium, Switzerland, Cyprus, Denmark, Spain, Finland, France, Greece, Italy, Japan, Kuwait, Latvia, Poland, Saudi Arabia, Slovakia;
📢 Compartir advertencia
Alert family and friends to keep them safe. Copy this quick alert message:
🚨 SAFETY ALERT: Gentuity, LLC - Gentuity HF-OCT Imaging System Model G10-01; Software version 23.2.13; Check if your household is affected: https://therecallfile.com/es/recalls/gentuity-hf-oct-imaging-system-model-g10-01-software-version-23-2-13/FDA-Z-1823-2026
Unirse a la lista de alertas
Reciba alertas por correo electrónico cuando se publiquen retiros críticos.
Support The Recall File
Help keep official recall alerts free, accessible, and fast for everyone.
Retiros Relacionados
UKField Safety Notices: 31 August to 4 September 2026
Field Safety Notices: 31 August to 4 September 2026
List of Field Safety Notices from 31 August to 4 September 2026....
AustraliaNutra-life Magnesium and Sleep Products and Musashi Pre Workout Chewables
Nutra-life Magnesium and Sleep Products and Musashi Pre Workout Chewables
Vitaco Health Australia Pty Ltd (Vitaco) is alerting customers that sucralose, an artificial sweetener, was used in 23 batches of Nutra-life and Musashi products rather than thaumatin, a natural sweet...
AustraliaAidacare Aspire Active Air 8 Pressure Care Air Mattress
Aidacare Aspire Active Air 8 Pressure Care Air Mattress
Aidacare Pty Ltd has updated the user manual for the Aspire Active Air 8 Pressure Care Mattress to add setup instructions and warnings about using the device in the presence of oxygen enriched environ...