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U.S. Department of Health and Human Services

Class 2 Device Recall ILUMAVision

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 Class 2 Device Recall ILUMAVisionsee related information
Date Initiated by FirmAugust 03, 2009
Date PostedSeptember 22, 2009
Recall Status1 Terminated 3 on January 27, 2010
Recall NumberZ-2239-2009
Recall Event ID 53132
510(K)NumberK081347 
Product Classification Picture archiving and communications system - Product Code LLZ
ProductILUMAVision Software, version 2.1.0 Picture Archiving and Communication system Product used as a tool for the pre-surgical planning of the placement of dental implants and pre-surgical fabrication of stents to aid in dental implant insertion. In addition, it is used for diagnostics and treatment planning in orthodontic, ENT and similar applications.
Code Information ILUMAVision Version 2.1.0
Recalling Firm/
Manufacturer		 IMTEC IMAGING L.L.C.
2401 N Commerce St
Ardmore OK 73401-1280
For Additional Information Contact
580-223-4561
Manufacturer Reason
for Recall		Under certain circumstances, software Version 2.1.0 has potential for incorrect data imaging and patient identification.
FDA Determined
Cause 2		Software design
ActionFirm sent notifications to all ILUMAVision customers on 8/3/2009 and offered upgraded software. The notification letter indicated the the reason for the recall and identified the potential issues associated with the device. Contact 3M IMTEC Technical Support at 1.800.879.9799, if there are any questions.
Quantity in Commerce223
DistributionWorldwide - US - Foreign: Australia, Austria, Belgium, Bulgaria, Canada, Croatia, Egypt, France, Germany, Hong Kong, Italy, Korea, Malaysia, Mexico, The Netherlands, Poland, Saudi Arabia, Spain, Turkey, and United Kingdom
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 = LLZ
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