Z-2463-2012 Class II Terminated
Recall Details
- Product Type
- Devices
- Report Date
- October 3, 2012
- Initiation Date
- July 30, 2012
- Termination Date
- October 13, 2016
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 366
Product Description
DEXIS Imaging Suite - catalog number 1.008.7932, version numbers 10.0.0 through 10.0.3 Radiological Image Processing System
Reason for Recall
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)
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.
Code Information
Catalog number 1.008.7932, version numbers 10.0.0 through 10.0.3