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U.S. Department of Health and Human Services

Class 3 Device Recall Imalux Niris OCT Imaging System Probe

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 Class 3 Device Recall Imalux Niris OCT Imaging System Probesee related information
Date Initiated by FirmDecember 22, 2011
Date PostedFebruary 01, 2012
Recall Status1 Terminated 3 on January 09, 2014
Recall NumberZ-0934-2012
Recall Event ID 60911
510(K)NumberK042894 
Product Classification System, imaging, optical coherence tomography (oct) - Product Code NQQ
ProductImalux 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.
Code Information Model Number 1300, Serial Number F464019
Recalling Firm/
Manufacturer		 Imalux Corporation
1771 E 30th St
Cleveland OH 44114-4407
For Additional Information Contact
216-502-0755 Ext. 301
Manufacturer 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.
FDA Determined
Cause 2		Process control
ActionImalux 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 CommerceOne Unit
DistributionNationwide Distribution only to Texas.
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database510(K)s with Product Code = NQQ
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