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U.S. Department of Health and Human Services

Class 2 Device Recall ILUMAVision

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 Class 2 Recall
ILUMAVision
see related information
Date Posted September 22, 2009
Recall Status1 Terminated on January 27, 2010
Recall Number Z-2239-2009
Recall Event ID 53132
Premarket Notification
510(K) Number
K081347 
Product Classification System, Image Processing, Radiological - 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, Oklahoma 73401-1280
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
DESIGN: 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 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
510(K) Database 510(K)s with Product Code = LLZ and Original Applicant = IMTEC CORP.
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