Recall of Gentuity HF-OCT Imaging System for Potential Measurement Issues
Areazine synthesizes this FDA recall directly from FDA's official public data feed. See our methodology for full source attribution and refresh cadence.
Gentuity, LLC is recalling 184 units of the Gentuity HF-OCT Imaging System due to a potential for repeated frames that could affect accurate longitudinal measurements during imaging.
What this FDA recall tells you, and what most readers miss
This notice was issued by FDA on May 3, 2026 and geographically references United States. Its severity classification of "medium" signals how the issuing agency weighs the risk of harm if no action is taken - "critical" and "high" tier alerts typically carry direct consumer actions, while "medium" and "low" tend toward informational guidance or monitoring advisories. The category it belongs to - FDA Recalls - determines the consumer-protection framework behind it, which shapes what remedies (refunds, replacements, repairs, or the recall itself) are available to affected consumers and which agency holds statutory responsibility for enforcement.
Most readers skim a notice like this, check whether they are personally affected, and move on. The more useful lens is to read it as a data point about the issuing system: how quickly FDA detected the hazard, how precise the geographic or product-identifier scope is, and whether similar notices have clustered in the same category or region in the last 90 days. Cluster patterns frequently precede a broader regulatory action, a single localized FDA recall is isolated; three of them within a quarter often indicate a supply-chain, infrastructure, or seasonal driver that will keep producing notices until something structural changes.
For decision-making, Areazine pairs each alert with the original agency URL, the full agency name, and a timestamp so you can verify the notice against the primary source before acting on it. Tags on this item (recall, product-safety, fda, Devices) map to related alerts in the same area of risk - browsing them together gives a clearer picture than any single notice alone, because the shape of an ongoing issue only becomes visible across multiple sequential alerts.
What Happened
Gentuity, LLC is issuing a voluntary recall for the Gentuity HF-OCT Imaging System because of the potential for repeated frames during HF-OCT pullback when using software versions from 21.11 to 23.3.13 with specific catheters. This issue could impact the accuracy of longitudinal measurements, and the recall aims to inform users on how to recognize, avoid, and mitigate this condition.
Which Products Are Affected
The affected product is the Gentuity HF-OCT Imaging System, Model G10-01, with software version 23.2.13. The recall involves 184 units total, including 28 units distributed in the United States and 156 units distributed outside the U.S. Distribution in the U.S. occurred nationwide in the states of CA, FL, GA, IL, MA, MN, NJ, NY, OH, PA, and TX. The product has UDI-DI: 00859910007032, and affected lot and serial numbers include: 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, and additional OUS lot numbers as listed in the recall notice. The official recall number is Z-1823-2026.
What You Should Do
Consumers and users should follow the instructions in the firm's notification letter, which was initiated via letter, to ensure they are informed on how to recognize, avoid, and mitigate the potential issue. Contact Gentuity, LLC at their address: 142 North Rd Ste G, Sudbury, MA 01776-1142, for information on returns, refunds, or further guidance related to this recall.
Why This Matters
This recall addresses a potential risk in medical devices that could lead to inaccurate measurements, potentially affecting patient care outcomes. It highlights the importance of software reliability in imaging systems used in healthcare settings to ensure accurate diagnostic procedures.
Source
This information is from the FDA recall notice, attributed to the U.S. Food and Drug Administration (FDA). For more details, refer to the FDA website using recall number Z-1823-2026 or event ID 98619.
Original source: FDA Official Notice ↗
Related FDA Recalls
All FDA Recalls →Frequently Asked Questions
Common questions about this FDA recall.