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Recall Observatory FDA recall evidence

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

July 30, 2012

Class II

Product summary

Firm
Imaging Sciences International, LLC
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

    reason.device_software_design · v1.0.0

    software will