Z-0934-2012

Imalux Niris OCT Imaging System Probe, Model Number 1300, Serial Number F464019, IMALUX Corporation...

Name: Z-0934-2012 Imalux Niris OCT Imaging System Probe, Model Number 1300, Serial Number F464019, IMALUX Corporation...
Creator: Imalux Corporation
Published: 2011-12-22
License: https://open.fda.gov/license/

Imalux Corporation / initiated 2011-12-22 / Terminated / root cause: manufacturing process

FDA source

Imalux Corporation began a recall of Imalux Niris OCT Imaging System Probe, Model Number 1300, Serial Number F464019, IMALUX Corporation, Cleveland, OH The Niris Imaging System probe is used with... on 2011-12-22. The reason FDA records is "During an FDA inspection, the firm was notified that the wrong tubing was used during the manufacture of the probe for the unit". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0934-2012
Status: Terminated
Initiated: 2011-12-22
Posted: 2012-02-01
Terminated: 2014-01-09
Recalling firm: Imalux Corporation
Product: 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 the patient tissue. A small electromechanical scanning mechanism in the probe moves the optical beam laterally across the tissue surface while simultaneously acquiring in-depth backscattering profile at each lateral position. The probe is not labeled or sold as sterile.
Product code: NQQ System, Imaging, Optical Coherence Tomography (Oct)
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.
Root cause tag: manufacturing process
FDA 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 in commerce: One Unit
Distribution: Nationwide Distribution only to Texas.
Product codes and lots: Model Number 1300, Serial Number F464019

Product code NQQ

K042894Class IIImalux Niris Imaging SystemImalux Corporation / cleared 2004-11-19

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)