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.
FDA Recall Z-2239-2009 · Posted 2009-09-22
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Recalling FirmIMTEC IMAGING L.L.C.
Recall StatusTerminated
Product CodeLLZ
Date Initiated2009-08-03
Date Terminated2010-01-27
Product Quantity223
Reason for Recall
Under certain circumstances, software Version 2.1.0 has potential for incorrect data imaging and patient identification.
Firm 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.
Root Cause
Software design
Distribution Pattern
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
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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