Z-2239-2009

ILUMAVision Software, version 2.1.0 Picture Archiving and Communication system Product used as a tool for the...

Name: Z-2239-2009 ILUMAVision Software, version 2.1.0 Picture Archiving and Communication system Product used as a tool for the...
Creator: Imtec Imaging L.l.c.
Published: 2009-08-03
License: https://open.fda.gov/license/

3M Imtec / initiated 2009-08-03 / Terminated / root cause: software

FDA source

IMTEC IMAGING L.L.C. began a recall of 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... on 2009-08-03. The reason FDA records is "Under certain circumstances, software Version 2.1.0 has potential for incorrect data imaging and patient identification". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as software.

Recall record

Recall number: Z-2239-2009
Status: Terminated
Initiated: 2009-08-03
Posted: 2009-09-22
Terminated: 2010-01-27
Recalling firm: 3M Imtec
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.
Product code: LLZ System, Image Processing, Radiological
Reason for recall: Under certain circumstances, software Version 2.1.0 has potential for incorrect data imaging and patient identification.
Root cause tag: software
FDA root cause: 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
Product codes and lots: ILUMAVision Version 2.1.0

Product code LLZ

K081347Class IIIluma VisionImtec Corp. / cleared 2008-05-28

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)