Recall Z-2239-2009 ยท LLZ System, Image Processing, Radiological
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.
| Date | Sep 22, 2009 (initiated Aug 3, 2009) |
| Status | Terminated |
| Reason | Under certain circumstances, software Version 2.1.0 has potential for incorrect data imaging and patient identification. |
| 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 | 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 |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K081347 | ILUMA VISION Imtec Corp., May 28, 2008 |