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U.S. Department of Health and Human Services

Class 2 Device Recall MM 4.0 and MIM 4.1

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 Class 2 Recall
MM 4.0 and MIM 4.1
see related information
Date Posted September 03, 2008
Recall Status1 Open
Recall Number Z-1827-2008
Recall Event ID 48114
Premarket Notification
510(K) Numbers
K060816  K071964 
Product Classification System, Image Processing, Radiological - 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, Ohio 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 2
CHANGE CONTROL (GMP - GOOD MANUFACTURING PRACTICE): 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 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
510(K) Database 510(K)s with Product Code = LLZ and Original Applicant = MIMVISTA CORP.
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