Cl Il ILUMAVision Software

Company:IMTEC IMAGING L.L.C.
Date of Enforcement Report 11/12/2009
Class:ll

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. Recall # Z-2239-2009

REASON
Under certain circumstances, software Version 2.1.0 has potential for incorrect data imaging and patient identification.

RECALLING FIRM/MANUFACTURER
IMTEC IMAGING L.L.C., Ardmore, OK, by letter on August 3, 2009. Firm initiated recall is ongoing.

VOLUME OF PRODUCT IN COMMERCE
223 units

DISTRIBUTION
Nationwide, 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

Upcoming Training

62304, FDA, and Emerging Standards for Medical Device and HealthIT
Instructors:  Brian Pate, John F. Murray, Jr
Location: Sunnyvale, CA, USA
Dates:  February 4-6, 2020
Registration Link

Receive $300 discount with Premium-Individual subscription purchase (or $333 per person for Premium-Company subscription)!  Email training@softwarecpr.com
to receive discount

QSS Software Validation
Planned Instructors:  Brian Pate, John F. Murray, Jr
Location: Boston, MA, USA
Dates:  June 2-4, 2020
For info on this course, email training@softwarecpr.com

Corporate Office

15148 Springview St
Tampa, FL 33624
USA
+1-781-721-2921
Partners located in the US (CA, FL, MA, MN) and Italy.