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Terminated

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.

FDA Recall Z-0934-2012 · Posted 2012-02-01

Recalling FirmImalux Corporation
Recall StatusTerminated
Product CodeNQQ
Date Initiated2011-12-22
Date Terminated2014-01-09
Product QuantityOne Unit

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.

Firm 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.

Root Cause

Process control

Distribution Pattern

Nationwide Distribution only to Texas.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K042894IMALUX NIRIS IMAGING SYSTEMImalux Corporation · 2004-11-19

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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