FDA Medical Device Recalls (openFDA)
Neuro Kinetics, Inc.: 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.
- Recall number
- Z-0966-2014
- Recalling firm
- Neuro Kinetics, Inc.
- 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.
- Status
- Terminated
- Initiated
- 2013-11-21
- Posted
- 2014-02-10
- Terminated
- 2015-07-20
- 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.
- Root cause
- No Marketing Application
- Action
- A recall notification letter, dated November 2013, was sent to Users. A follow up letter regarding scheduling removal of the software is planned for December 2013.
- Quantity
- 148
- Distribution
- Distributed USA (nationwide) and the country of Canada.
- Lot, serial or model codes
- Software versions affected: 6.7.004, 6.8. 6.9, 6.10, 7.0, 7.0.1, and 7.1
- 510(k) numbers
- ["K083603"]
- PMA numbers
- not on file
- Product code
- GWN
- Firm FEI
- 2519945
- Firm city
- Pittsburgh
- Firm state
- PA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28