Device product
DEXIS Imaging Suite - catalog number 1.008.7932, version numbers 10.0.0 through 10.0.3 Radiological Image Processing System
Z-2463-2012
Product summary
- Event
- Event 62830
- Status
- Terminated
- Classification
- Class II
- Quantity
- 366
- Official record key
device-enforcement:Z-2463-2012
Official wording
Reason: A condition can occur during renumbering of the patient database using the DEXCopy feature. When renumbering is being performed using the DEXCopy feature and multiple patients with an identical name are present, the software will assign all subsequent records to the first patient record, resulting in mixed patient records. In order for this problem to occur several conditions need to be met: 1)
Code information: Catalog number 1.008.7932, version numbers 10.0.0 through 10.0.3
Distribution pattern: Worldwide Distribution - USA including Washington, DC, AL, AZ, AR, CA, CO, CT, DE, FL, GA, IL, IN, IA, KS, KY, LA, MD, MA, MI, MN, MO, NE, NV, NH, NJ, NM, NY, NC, ND, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, WA, WI and the country of Canada.
Derived failure modes
-
Device software or design
software will