IMTEC IMAGING L.L.C. 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. Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
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.
Brand
IMTEC IMAGING L.L.C.
Lot Codes / Batch Numbers
ILUMAVision Version 2.1.0
Products Sold
ILUMAVision Version 2.1.0
IMTEC IMAGING L.L.C. is recalling ILUMAVision Software, version 2.1.0 Picture Archiving and Communication system Product used as a to due to Under certain circumstances, software Version 2.1.0 has potential for incorrect data imaging and patient identification.. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Under certain circumstances, software Version 2.1.0 has potential for incorrect data imaging and patient identification.
Recommended Action
Per FDA guidance
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.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026