BEUDAMED
    FDA Recall 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.

    Recall: Z-0934-2012 · Initiated December 22, 2011

    Recall

    Recall Number
    Z-0934-2012
    Event Number
    60911
    Firm
    Imalux Corporation
    FEI Number
    3003883695
    Product Code
    NQQ
    Status
    Terminated
    Root Cause
    Process control
    Initiated
    December 22, 2011
    Posted
    February 1, 2012
    Terminated
    January 9, 2014
    Address
    1771 E 30th St, Cleveland, OH, 44114-4407

    Description

    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.

    Reason

    During an FDA inspection, the firm was notified that the wrong tubing was used during the manufacture of the probe for the unit.

    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.

    Distribution

    Nationwide Distribution only to Texas.

    Quantity

    One Unit