FDAFDA · Food and drugs·Recall number Z-2463-2012
DEXIS Imaging Suite - catalog number 1.008.7932, version numbers 10.0.0 through 10.0.3 Radiological Image Processing System
Published October 3, 2012 · Recall initiated: July 30, 2012
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
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)
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Imaging Sciences International, LLC
- Distributor
- 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.
- Lot
- Catalog number 1.008.7932, version numbers 10.0.0 through 10.0.3
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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