Class 2 Device Recall MM 4.0 and MIM 4.1

• Date Initiated by Firm: April 23, 2008
• Date Posted: September 03, 2008
• Recall Status: Terminated on April 14, 2015
• Recall Number: Z-1827-2008
• Recall Event ID: 48114
• 510(K)Number: K060816 K071964
• Product Classification: Radiological Imaging Processing System - Product Code LLZ
• 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.
• Code Information: Model #'s 4.0.2-4.0.5 & 4.1.0-4.1.2
• Recalling Firm/ Manufacturer: MIMvista Corp; 25200 Chagrin Blvd Ste 200; Cleveland OH 44122-5684
• For Additional Information Contact: Lynn Hanigan; 216-455-0600
• Manufacturer Reason for Recall: 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.
• FDA Determined Cause: Software change control
• Action: MIMvista Corp has issued this safety recall notification for MIM versions 4.0.2 through 4.1.2. An error has been discovered in the way SW and contour statistics are measured and reported under some specific circumstances. Users of these versions should immediately contact MIMvista support at (866) 421-2536 or visit httv://www.mimvista.com/recall/ to obtain complete instructions regarding this error. A new version that corrects this problem is available on the Downloads page, http://www,mimvista.com/download
• Quantity in Commerce: 221
• Distribution: The product was sold in the following US states: AL, AR, AZ, CA, CO, DC, DE, FL, GA, IA, ID, IL, IN, LA, MA, MD, MI, MO, MS, MT, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, TN, TX, VA, WA, WI & WV. It was also sold in Europe, Asia and Canada.
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.

• 510(K) Database: 510(K)s with Product Code = LLZ