Imaging Sciences International, LLC: Medical Device Recall in 2012 - (Recall #: Z-2463-2012)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2012.

Data Source: FDA.

Product Description:

DEXIS Imaging Suite - catalog number 1.008.7932, version numbers 10.0.0 through 10.0.3 Radiological Image Processing System

Product Classification:

Class II

Date Initiated: July 30, 2012

Date Posted: October 3, 2012

Recall Number: Z-2463-2012

Event ID: 62830

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)

Status: Terminated

Product Quantity: 366

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.

Voluntary or Mandated:

Voluntary: Firm initiated