The Recall Desk
HighFDA (Devices)·Z-1795-2015·Announced 2015-06-24

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.

What this means for you

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 cent
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.