I-Portal¿ NOTC and VNG — Class II medical device recall Z-1795-2015
Terminated recall by Neuro Kinetics, Inc., reported 2015-06-24, distributed nationwide. complaints of system malfunction and unintended, sudden movement at start up. No injuries reported.
| Recall number | Z-1795-2015 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Neuro Kinetics, Inc., Pittsburgh, PA, United States |
| Recall initiated | 2015-04-30 |
| Classified | 2015-06-12 |
| Reported by FDA | 2015-06-24 |
| Terminated | 2017-04-17 |
| Distributed | Nationwide (US) |
| Countries outside the US | CA, MX |
| Quantity | 140 |
| Reason classes | device malfunction |
| Model numbers | SVNG-1, SVNG-2, SVNG-3 |
Product
I-Portal¿ NOTC and VNG; a device used to measure, record, or visually display the involuntary movements (nystagmus) of the eyeball, indicated for use as a diagnostic tool to assist trained clinicians in their analysis of vestibular disorders, which requires the separation of central vs. peripheral nervous system deficits.
Reason for recall
complaints of system malfunction and unintended, sudden movement at start up. No injuries reported.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1795-2015. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.