FDAFDA · Food and drugs·Recall number Z-0966-2014
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.
Published February 19, 2014 · Recall initiated: November 21, 2013
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
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.
What to do
Voluntary: Firm initiated · E-Mail
Recall details
- Manufacturer
- Neuro Kinetics, Inc.
- Distributor
- Distributed USA (nationwide) and the country of Canada.
- Lot
- Software versions affected: 6.7.004, 6.8. 6.9, 6.10, 7.0, 7.0.1, and 7.1
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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