Company: MIMvista Corp
Date of Enforcement Report 9/17/2008
Class:ll

PRODUCT
MIM 4.0 and MIM 4.1 is a software package designed for use in diagnostic imaging. It is a stand alone software package which operates on Windows 2000/XP; Recall # Z-1827-2008

REASON
In MIM (4.0.2-4.0.5) and MIM (4.1.0-4.1.2) versions, there is an error that may occur during the calculation of statistics using the SUV Tool or Contour Statistics. It will occur only under the following specific circumstance: A fusion of a primary volume which has a Z-Axis slice separation larger than that of the secondary volume and statistics are reported on the secondary volume.

RECALLING FIRM/MANUFACTURER
MIMvista Corp, Cleveland, OH, by telephone on April 23, 2008. Firm initiated recall is ongoing.

VOLUME OF PRODUCT IN COMMERCE
221 units

DISTRIBUTION
Nationwide