FDA-Device2012-10-03Class II
DEXIS Imaging Suite - catalog number 1.008.7932, version numbers 10.0.0 through 10.0.3 Radiological Image Processing System
Imaging Sciences International, LLC
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)
Sold states
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.
Affected count
366
Manufactured in
1910 North Penn Rd, N/A, Hatfield, PA, United States
Products
DEXIS Imaging Suite - catalog number 1.008.7932, version numbers 10.0.0 through 10.0.3 Radiological Image Processing System
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2463-2012Don't want to check this manually?
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