FDA Device recall Z-0966-2014
Normative Data Template CD for use with the I-Portal devices
- FDA Device
- Class II
- terminated
- Published 2014-02-19
On 2014-02-19 the FDA classified a Class II recall of Normative Data Template CD for use with the I-Portal devices by Neuro Kinetics, citing 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.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0966-2014 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2013-11-21 |
| Published | 2014-02-19 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Neuro Kinetics |
| Distribution | US |
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.
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.
Identifiers
| code_info | Software versions affected: 6.7.004, 6.8. 6.9, 6.10, 7.0, 7.0.1, and 7.1 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0966-2014%22
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