MIM 4.0 and MIM 4.1 is a software package designed for use in diagnostic imaging. It is a stand alone software package w
FDA device recall Z-1827-2008 · posted 2008-09-03 · Terminated
Recall details
- Recalling firm
- MIMvista Corp
- 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.
- Action taken
- 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
- Root cause
- Software change control
- Status
- Terminated
- Product code
- LLZ
- Quantity affected
- 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
- Date initiated
- 2008-04-23
- Date posted
- 2008-09-03
- Date terminated
- 2015-04-14
- Location
- Cleveland, OH
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| MIM 4.1 (SEASTAR) (K071964) | Mimvista Corp. | 2007-09-26 |
| MIM 4.0 (NEURO (K060816) | Mimvista Corp. | 2006-05-16 |