Recall Z-0934-2012 ยท NQQ System, Imaging, Optical Coherence Tomography (Oct)
Imalux Corporation
Imalux Niris OCT Imaging System Probe, Model Number 1300, Serial Number F464019, IMALUX Corporation, Cleveland, OH The Niris Imaging System probe is used with the Niris Imaging System. The Niris Imaging System employs Optical Coherence Tomography (OCT), which can be used to construct high spatial resolution. The probe, is attached to the Imaging Console, and is used to direct light to and from th
| Date | Feb 1, 2012 (initiated Dec 22, 2011) |
| Status | Terminated |
| Reason | During an FDA inspection, the firm was notified that the wrong tubing was used during the manufacture of the probe for the unit. |
| Root cause | Process control |
| Action | 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. |
| Quantity | One Unit |
| Distribution | Nationwide Distribution only to Texas. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K042894 | IMALUX NIRIS IMAGING SYSTEM Imalux Corporation, Nov 19, 2004 |