Normative Data Template CD for use with the I-Portal devices. Used to measure, record, or visually display the involunta
FDA device recall Z-0966-2014 · posted 2014-02-10 · Terminated
Recall details
- Recalling firm
- Neuro Kinetics, Inc.
- Reason for recall
- 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.
- Action taken
- 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.
- Root cause
- No Marketing Application
- Status
- Terminated
- Product code
- GWN
- Quantity affected
- 148
- Distribution
- Distributed USA (nationwide) and the country of Canada.
- Date initiated
- 2013-11-21
- Date posted
- 2014-02-10
- Date terminated
- 2015-07-20
- Location
- Pittsburgh, PA
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| I-PORTAL 4D VIDEO OCULOGRAPHY EYE TRACKING SYSTEM (VOG), I-PORTAL VIDEO NYSTAGMOGRAPHY SYSTEM (VNG), I-PORTAL NEURO OTOL (K083603) | Neuro Kinetics | 2009-08-06 |