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

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  • 62304 compliance
  • Regulatory submission pre-review
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Corporate Office

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