VEST 6.6 or earlier software for use with Neuro Kinetics products. The device is used for vestibular testing.
FDA device recall Z-2253-2009 · posted 2009-09-30 · Terminated
Recall details
- Recalling firm
- Neuro Kinetics
- Reason for recall
- Marketed without a 510k or PMA submission to include the normative data display.
- Action taken
- A notification letter was emailed to customers starting on August 10, 2009. The letter stated that the normative display needed to be removed pending FDA clearance. Direct questions to Neuro Kinetics, Inc. by calling 1-412-963-6649.
- Root cause
- PMA
- Status
- Terminated
- Product code
- LXV
- Quantity affected
- 72 units
- Distribution
- Worldwide Distribution -- US (states of AL, AZ, CA, DC, FL, GA, HI, IN, MA, MD, MI, MN, NC, NY, OR, PA, SC, TN, UT, VA, WA, and WV), Korea, United Kingdom, and Spain.
- Date initiated
- 2009-07-24
- Date posted
- 2009-09-30
- Date terminated
- 2010-01-13
- 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 |