Device product
I-Portal¿ NOTC and VNG; a device used to measure, record, or visually display the involuntary movements (nystagmus) of the eyeball, indicated for use as a diagnostic tool to assist trained clinicians in their analysis of vestibular disorders, which requires the separation of central vs. peripheral nervous system deficits.
Z-1795-2015
Product summary
- Event
- Event 71264
- Status
- Terminated
- Classification
- Class II
- Quantity
- 140
- Official record key
device-enforcement:Z-1795-2015
Official wording
Reason: complaints of system malfunction and unintended, sudden movement at start up. No injuries reported.
Code information: Model Numbers NOTC-S, NOTC-P, NOTC-C, NOTC-O, SVNG-1, SVNG-2, SVNG-3
Distribution pattern: Worldwide distribution - US (nationwide) and Internationally to Canada and Mexico.
Derived failure modes
-
Unknown
complaints of system malfunction and unintended, sudden movement at start up. No injuries reported.