Skip to content
Recall Observatory FDA recall evidence

Device product

Normative Data Template CD for use with the I-Portal devices. Used to measure, record, or visually display the involuntary movements (nystagmus) of the eyeball.

Z-0966-2014

November 21, 2013

Class II

Product summary

Firm
Neuro Kinetics, Inc.
Event
Event 66995
Status
Terminated
Classification
Class II
Quantity
148
Official record key
device-enforcement:Z-0966-2014

Official wording

Reason: The data provided on the Normative Data Template CD for use with the I-Portal devices has not received clearance by FDA through the premarket 510(k) notification process.

Code information: Software versions affected: 6.7.004, 6.8. 6.9, 6.10, 7.0, 7.0.1, and 7.1

Distribution pattern: Distributed USA (nationwide) and the country of Canada.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    The data provided on the Normative Data Template CD for use with the I-Portal devices has not received clearance by FDA through the premarket 510(k) notification process.