Sep

2008

Cl Il MIMvista Corp

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

About the author

Amy Sellers

Amy enjoys researching and writing about developments in medical technology and how that intersects with US law. She received her J.D. from the University of Florida Levin College of Law in 2020 and now works as a Regulatory Associate for SoftwareCPR®, a general-purpose regulatory consulting firm that is recognized globally for their expertise with standards and national regulations pertaining to medical device, mobile medical app, and HealthIT software.

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Cl Il MIMvista Corp

Amy Sellers

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