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

Software Verification

Do you have gaps with IEC 62304 compliance or with FDA expectations for software verification?  We can help you quickly remediate gaps with unit verification including unit testing, code review, and static analysis, as well as integration and system verification testing.  Call us at 781-721-2921 or email office@softwarecpr.com to start a conversation.  We can provide estimates of cost and support your development tools.

Corporate Office

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