Neuro Kinetics Recalls I-Portal NOTC and VNG Devices Due to Malfunction
Neuro Kinetics is recalling 140 I-Portal NOTC and VNG devices due to system malfunctions and unintended sudden movements at startup. No injuries have been reported.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a risk-of-harm product (unintended sudden movement) where injury has not yet been reported, which aligns with the High severity criteria.
Plain-English summary
Neuro Kinetics, Inc. is recalling 140 units of the I-Portal NOTC and VNG devices. These medical devices are used to measure, record, or visually display involuntary eye movements (nystagmus) to assist clinicians in analyzing vestibular disorders. The affected model numbers are NOTC-S, NOTC-P, NOTC-C, NOTC-O, SVNG-1, SVNG-2, and SVNG-3.
The recall was initiated due to complaints of system malfunction and unintended, sudden movement at startup. The devices were distributed nationwide in the United States, as well as internationally to Canada and Mexico.
No injuries have been reported in connection with this recall. Consumers and healthcare providers should stop using the affected devices and contact Neuro Kinetics, Inc. for further instructions on the recall process.
The recalled product
- 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…
- Manufacturer
- Neuro Kinetics, Inc.
- Affected units
- 140
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (7)
- Model Numbers NOTC-S
- NOTC-P
- NOTC-C
- NOTC-O
- SVNG-1
- SVNG-2
- SVNG-3
Distribution
Distributed nationwide across the United States.
Related recalls
Same manufacturer · Neuro Kinetics, Inc.
See all →- ModerateNeuro Kinetics I-Portal NOTC System Recalled for Incorrect Investigational Labeling
FDA (Devices) · 2015-09-09
- ModerateNeuro Kinetics I-Portal Normative Data Template CD Recalled for Lack of FDA Clearance
FDA (Devices) · 2014-02-19
Same hazard · malfunction
See all →- ModerateCriticare nGenuity Patient Monitor Recalled for Capnography Setup Error
FDA (Devices) · 2026-09-30
- HighFresenius BlueStar Hemodialysis Machines Recalled for Alarm Defects
FDA (Devices) · 2026-09-02
- ModerateOlympus 4K UHD LCD Monitors Recalled Due to Potential Connector Faults
FDA (Devices) · 2026-07-29
- High
- ModeratePhilips Azurion 3M15 Medical Imaging Systems Recalled Due to Software Issue
FDA (Devices) · 2026-06-10
Similar recalls
- ModerateNeuro Kinetics I-Portal NOTC System Recalled for Incorrect Investigational Labeling
FDA (Devices) · 2015-09-09
- ModerateNeuro Kinetics I-Portal Normative Data Template CD Recalled for Lack of FDA Clearance
FDA (Devices) · 2014-02-19
- ModerateMagstim Recalls Neurosign 100 Intraoperative Nerve Monitors for Voltage Configuration Error
FDA (Devices) · 2021-01-27
- HighInnokas Medical Recalls CARESCAPE VC150 Vital Signs Monitors for Shutdown Defect
FDA (Devices) · 2015-11-18
- SevereNIM Vital Nerve Monitoring Systems Recalled for False Negative Risk
FDA (Devices) · 2024-07-31
- HighGE Healthcare Recalls NeuroMuscular Transmission Modules for Inaccurate Readings
FDA (Devices) · 2014-05-28