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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 ILUMAVision see related information
Date Initiated by Firm August 03, 2009
Date Posted September 22, 2009
Recall Status1 Terminated 3 on January 27, 2010
Recall Number Z-2239-2009
Recall Event ID 53132
510(K)Number K081347  
Product Classification Picture archiving and communications system - Product Code LLZ
Product ILUMAVision 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
Action Firm 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 Commerce 223
Distribution Worldwide - 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 Cycle TPLC 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) Database 510(K)s with Product Code = LLZ and Original Applicant = IMTEC CORP.
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