Z-1827-2008

MIM 4.0 and MIM 4.1 is a software package designed for use in diagnostic imaging. It is a stand alone...

Name: Z-1827-2008 MIM 4.0 and MIM 4.1 is a software package designed for use in diagnostic imaging. It is a stand alone...
Creator: MIMvista Corp
Published: 2008-04-23
License: https://open.fda.gov/license/

MIM Software Inc / initiated 2008-04-23 / Terminated / root cause: software

FDA source

MIMvista Corp began a recall of 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 on 2008-04-23. The reason FDA records is "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as software.

Recall record

Recall number: Z-1827-2008
Status: Terminated
Initiated: 2008-04-23
Posted: 2008-09-03
Terminated: 2015-04-14
Recalling firm: MIM Software Inc
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.
Product code: LLZ System, Image Processing, Radiological
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.
Root cause tag: software
FDA 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 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.
Product codes and lots: Model #'s 4.0.2-4.0.5 & 4.1.0-4.1.2

Product code LLZ

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)