I-Portal NOTC and VNG; a device used to measure, record, or visually display the involuntary movements (nystagmus) of th
FDA device recall Z-1795-2015 · posted 2015-06-12 · Terminated
Recall details
- Recalling firm
- Neuro Kinetics, Inc.
- Reason for recall
- complaints of system malfunction and unintended, sudden movement at start up. No injuries reported.
- Action taken
- Neuro Kinetics sent a Field Correction Advisory letter dated April 2015, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers with the affected product were instructed to contact Customer Service if a malfunction is encountered and not to use the device until it has been assessed and corrected by Nuerokinetics. Customers with questions should call 412-963-6649.
- Root cause
- Software design
- Status
- Terminated
- Product code
- GWN
- Quantity affected
- 140
- Distribution
- Worldwide distribution - US (nationwide) and Internationally to Canada and Mexico.
- Date initiated
- 2015-04-30
- Date posted
- 2015-06-12
- Date terminated
- 2017-04-17
- Location
- Pittsburgh, PA
Monitor recalls programmatically
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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 |