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Terminated

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.

FDA Recall Z-1795-2015 · Posted 2015-06-12

Recalling FirmNeuro Kinetics, Inc.
Recall StatusTerminated
Product CodeGWN
Date Initiated2015-04-30
Date Terminated2017-04-17
Product Quantity140

Reason for Recall

complaints of system malfunction and unintended, sudden movement at start up. No injuries reported.

Firm Action

Neuro Kinetics sent a Field Correction Advisory letter dated April 2015, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers with the affected product were instructed to contact Customer Service if a malfunction is encountered and not to use the device until it has been assessed and corrected by Nuerokinetics. Customers with questions should call 412-963-6649.

Root Cause

Software design

Distribution Pattern

Worldwide distribution - US (nationwide) and Internationally to Canada and Mexico.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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