Recall Z-1827-2008 ยท LLZ System, Image Processing, Radiological
MIMvista Corp
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.
| Date | Sep 3, 2008 (initiated Apr 23, 2008) |
| Status | Terminated |
| 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. |
| Root 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 | 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. |
| FDA record | Open on fda.gov |