Imalux Niris OCT Imaging System Probe, Model Number 1300, Serial Number F464019, IMALUX Corporation, Cleveland, OH The N
FDA device recall Z-0934-2012 · posted 2012-02-01 · Terminated
Recall details
- Recalling firm
- Imalux Corporation
- Reason for recall
- During an FDA inspection, the firm was notified that the wrong tubing was used during the manufacture of the probe for the unit.
- Action taken
- Imalux Corp contacted their one customer via telephone on December 14, 2011. They informed the customer of the problem and requested the probe returned. The probe involved was returned and received by Imalux on December 22, 2011, and will be stored offsite in quarantine. Any further questions please call (216) 502-0755 ext. 301.
- Root cause
- Process control
- Status
- Terminated
- Product code
- NQQ
- Quantity affected
- One Unit
- Distribution
- Nationwide Distribution only to Texas.
- Date initiated
- 2011-12-22
- Date posted
- 2012-02-01
- Date terminated
- 2014-01-09
- Location
- Cleveland, OH
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| IMALUX NIRIS IMAGING SYSTEM (K042894) | Imalux Corporation | 2004-11-19 |